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Test Object Item/Parameter Standard or Method
Medical
material 		Determining
Radiopacity For
Medical Use 		Standard Test Methods for Determining Radiopacity for Medical
Use ASTM F640-23
Standard Test Methods for Determining Radiopacity for Medical
Use ASTM F640-20
Internal
Pressurization
Failure Resistance 		Standard Test Methods for Internal Pressurization Failure
Resistance of Unrestrained Packages ASTM F1140/F1140M-
13(2020)e1
Ink OrCoating
Adhesion 		Standard Practice for Evaluating Ink or Coating Adhesion to
Flexible   Packaging   Materials   Using   Tape   ASTM
F2252/F2252M-13(2018)
Tension Standard Test Methods for Vulcanized Rubber and Thermoplastic
Elastomers-Tension ASTM D412-16(2021)
medical
material 		Microbial Limit                                IFICATE
European pharmacopoeia EP10.32.6.13
Sterility Test European pharmacopoeia EP10.02.6.1
medical
material 		Microbial Limit U.S.Pharmacopeia 62 USP 2022
Sterility Test U.S.Pharmacopeia 71 USP2022

Medical
Polymer
Products 		Ray Detectability Medical polymer products-Test methods of radiopacity YY/T
0586-2016
Medical polymer products-Test methods of radiopacity YY/T
0586-2005
Medical
material 		Color Colour standard for paint film GB/T 3181-2008
heat stability Plastics—Thermogravimetry (TG)of polymers—Part 1:General
principles GB/T 33047.1-2016
Melt Mass Flow
RateTIONALACC 		     Plastics--Determination of the melt mass-now rate (MFR)and
    melt volume-flow rate(MVR)of thermoplastics--Part 1:Standard
R
method GB/T 3682.1-2018
          SCHED
Melting and
crystallization
temperatures 		Plastics-DifferentiabITATscanningRTIF calorimetry(DSC)Part
3:Determination of temperature and enthalpy of melting and
crystallization ISO 11357-3:2018
Plastics-Differential   scanning     calorimetry(DSC)Part
3:Determination of temperature and enthalpy of melting and
crystallization GB/T 19466.3-2004
Oxidative induction   Plastics-Differential scanning calorimetry(DSC)Part 6:
Determination of oxidation induction time(isothermal OIT)and
oxidationinduction temperature(dynamic OIT)GB/T 19466.6-
2009
Plastics-Differential scanning calorimetry(DSC)Part 6 :
Determination of oxidation induction time(isothermal OIT)and
oxidationinduction temperature(dynamic OIT)ISO 11357-6:2018
Moisture    Chemical products for industrial use-General method
fordetermination of water content-The loss of mass on drying
method GB/T 6284-2006
Plastics-Determination of water content for Polyethylene SH/T
1770-2010
Ash Content Plastics-Determination of ash-Part 1:General methods GB/T
9345.1-2008
Plastics-Determination of ash-Part 1:General methods ISO 3451-
1:2019
Grain size     Plastics-Vinyl chloride homopolymer and copolymer
resinsParticle size determination by mechanical sieving GB/T
21843-2008
    Plastics-Vinyl chloride homopolymer and copolymer
resinsParticle size determination by mechanical sieving ISO
 22498:2005
Particle Size
Analysis—Laser
Diffraction Methods 		Particle T size sanalysis-Laser cdiffraction||TmethodsESISO
 13320:2020
Compressive
Properties 		Plastics--Determiantion of compressive properties GB/T 1041-
2008

Plastics--Determiantion of compressive properties ISO604:2002
Medical
material 		Surface Roughness Geometrical      Product      Specifications(GPS)--Surface
texture:Profile method--Rules and procedures for the assessment
of surface texture GB/T 10610-2009
Geometrical Product Specifications(GPS)-Surface texture :
Profile method-Surface roughness parameters and their values
GB/T 1031-2009
Geometrical product specifications(GPS)—Surface texture:
Profile—Part 3:Specification operators ISO21920-3:2021
Medical
material 		A Population Of
Microorganisms 		Sterilization of health care products-Microbiological methods-
Part 1:Determination of a population of microorganisms on
products GB/T19973.1-2023
Medical
material 		Shore Hardness Plastics and ebonite-Determination of indentation hardness by
means of a durometer(shore hardness)GB/T2411-2008
Rubber,vulcanized or thermoplastic-Determination of indentation
  hardness-Part 1:Duromerer method (Shore hardness)GB/T
531.1-2008
Characterization and testing methods of recycled
polyethylene(PE)GB/T 39199-20204.1
  Rubber,vulcanized or thermoplastic —Determination of
hardness —Part 4:Indentation hardness by durometer method
(Shore hardness)ISO48-4:2018
Vickers Hardness Metallic materials--Vickers hardness test--Part 1:Test method
GB/T 4340.1-2009
  Metallic materials VLCEVickers hardness testYAS Part S2:
Verification and calibration of testing machines ISO6507-2:2018
Metallic materials--Vickers hardness test--Part 1:Test method
ISO 6507-1:2023
Rockwell Hardness Metallic materials-Rockwell hardness test-Part 1:Test method
ISO 6508-1:2023
Metallic materials-Rockwell hardness test-Part 1:Test method
GB/T 230.1-2018
Water Content Gas analysis--Determination of moisture--Part 2:Dew point
method GB/T5832.2-2016
Metallic Thickness Metallic and other inorganic coatings--Review of methods of
measurement of thickness GB/T6463-2005
   Metallic and other inorganiccoatings-Review of methods
ofmeasurement ofthickness ISO3882:2024
Metal Coating Coating classifications for metal product Technical conditions
YY/T0076-1992
Flexural Properties Plastics -Determination of flexural properties GB/T9341-2008
Plastics -Determination of flexural properties ISO 178:2019
Metallic materials——Bend test GB/T 232-2010
Determination Of
Volatile Organic
Compounds In
Indoor And
Laboratory Air 		Indoor air --Part 6:Determination of volatile organic compounds
in indoor and laboratory air by Tenax TA adsorbent,thermal
desorption and active sampling by gas chromatography using
mass spectrometry (MS)or mass spectrometry-flame ionization
detector (MS-FID)ISO 16000-6:2021
medical
material
Sterility Test
A  NATIONAL  ACCR
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 1101
EDITATION       SERVICE       FOR       CONFORMITYASSESSM
          SCHED
Viscosity 		ULE    OF    ACCREDITATION    CERTIFICATE
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0633
Ultraviolet
Absorption 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0401
Refractive Index Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0622
pH Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0631
Cadmium Content Pharmacopoeia of the People's Republic of China (Part II)
Chinese Pharmacopoeia 2010 Edition II Appendix IVD
Osmotic Pressure
A      NATIONALACCR
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0632
EDITATION      SERVICE      FOR      CONFORMITYASSESSM
          SCHED
Appearance 		ULE    OF    ACCREDITATION    CERTIFICATE
Pharmacopoeia of the People's Republic of China (Part II)
Chinese Pharmacopoeia 2010 Edition II Appendix XH
Microbial Limit Chinese Pharmacopoeia 2020 Edition Part IV General Rule 1105
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 1106
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 1107
Iron Content Pharmacopoeia of the People's Republic of China (Part II)
Chinese Pharmacopoeia 2010 Edition II Appendix VⅢ G
Heavy metal test
(as Pb) 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0821
Arsenic test Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0822

Dry Weight Loss
ANATIONAL      ACC
Pharmacopoeia of the People's Republic of China (Part IV)
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0831
REDITATIC      VICE    FOR     CONFORMITY

           SCHED
Sulfate
ULE    OF    ACCREDITATION    CERTIFICATE
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0802
Burning Residue Chinese Pharmacopoeia 2010 Edition II Appendix VⅢN
Protein
identification 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0402
Metal ion analysis
(Ba,Cr,Cu,
Pb,Sn,Fe,Cd,As) 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0406
Flame Photometry Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0407
Metal analysis Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0407
A   NATIONAL   ACC
ConductivitysCHED 		REDITATIONSERVICE      FOR      CONFORMITY      ASSESSME
LChinese Pharmacopoeia 2020 Edition Part IV General Rule 0681
Content
determinantion 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0701
Chloride Assay Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0801
Sulfide Test Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0803
Selenium Test Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0804
Fluorine Test Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0805
A   NATIONAL   ACC
Iron Salt TestcHED 		REDITA TON      SERVICE      FOR      CONFORMITYASSESSM
LChinese Pharmacopoeia 2020 Edition Part IV General Rule 0807
Ammonium Salt
Test 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0808
Moisture Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0832
Burning Residue Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0841
Alcohol residue
determination 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0841
methanoltest Chinese Pharmacopoeia 2020 Edition Part IVGeneral Rule 0841
A   NATIONAL   ACC
Solution ColorCHED 		REDITATIONSERVICE      FOR      CONFORMITY      ASSESSME
LChinese Pharmacopoeia 2020 Edition Part IV General Rule 0901
The Solution Color Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0902
Insoluble Particles
Test 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0903
Visible Foreign
Matter 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0904
Dissolution And
Release 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0931
Minimum Fill Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0942
Examination of the
aerodynamic
characteristics of
fine particles in
inhaled preparations
SERVICE          FOR          CONFORMITYASSESSM
Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0951
Adhesion Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0952
Size and size
distribution 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0982
Cytotoxin Chinese Pharmacopoeia 2020 Edition Part IV General Rule 1143
microscopic
identification 		Chinese Pharmacopoeia 2015 Edition Part IV General Rule 2001
Ash Content Test Chinese Pharmacopoeia 2015 Edition Part IV General Rule 2302
Determination Of
Lead,Cadmium,
Arsenic,Mereury
And Copper 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 2321
Phosphorus content Chinese Pharmacopoeia 2020 Edition Part IV General Rule 3103
Sodium Chloride
Test 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 3107
HPMC(hydroxypro
pyl methylcellulose) 		Chinese Pharmacopoeia 2020 Edition Part IV P739
Bacteriostasis Chinese Pharmacopoeia 2020 Edition Part IV General Rule 1121
microscopic
identification(size) 		Chinese Pharmacopoeia 2020 Edition Part IV General Rule 2001
Medical
material 		All Of Items Polypropylene material for manufacture of infusion,transfusion
and injection equipments for medical use YY/T0242-2007
Medical
material 		All Of Items Plasticized poly(vinyl chloride)compounds for transfusion
(infusion)equipment GB/T 15593-2020
Medical
material 		Part Of Items Plastics-Recycled plastics-Part 2:Polyethylene(PE)materials
GB/T 40006.2-2021

Medical
material 		Part Of Items Plastics-Recycled plastic-Part 1:General rules GB/T 40006.1-
2021
Medical
material 		All Of Items Characterization   and   testing   methods  of   recycled
polyethylene(PE)GB/T39199-2020
Medical
material 		Part Of Items Polyethylene material for manufacture of infusion,transfusion and
injectionequipments for medical use YY/T 0114-2008
Medical
material 		Ethylene Oxide
Sterilization
Residuals 		Biological evaluation of medical devices-Part 7:Ethylene oxide
sterilization residuals ISO 10993-7:2008+A1:2019

Verification Of
Ethylene Oxide
Sterilization 		Sterilization ofhealth-careproducts-  Ethylene oxide
Requirements for the development,validation and routine control
ofa sterilization   process    for    medicaldevices    ISO
11135:2014+A1:2018
Density Plastics --Methods for determining the density of non-cellular
plastics --Part 1:Immersion method,liquid pycnometer method
and titration method ISO1183-1:2019
Skin absorbed dose Chemicals—Testing method for skin absorption—In vitro GB/T
27818-2011
Responsive imageFar-infraredLACCF
property 		Test method of infrared heater GB/T7287-2008
Health functional textiles CAS 115-2005
Textiles—Testing and evaluation for far infrared radiation
properties GB/T30127-2013
DEHP    Guidance of determination for di(2-ethylhexyl)phthalate
(DEHP)released from PVC medical devices YY/T0927-2014
cyclohexanone   Test method for cyclohexanone released from infusion and
transfusion equipments for medical use YY/T 1658-2019
Surface antibacterial
activity 		Measurement of antibacterial activity on plastics and other non-
porous surfaces ISO22196:2011
Notched Impact
Strength Of
Cantilever Beam 		Plastics --Determination of Izod impact strength ISO 180:2023
Resistant Testing
Method 		Evaluation of the corrosion test results of the metal deposits for
the light industrial products QB/T3832-1999
Particulate Pollution Test methods for particle contamination of infusion,transfusion
and injection equipments for medical use YY/T 1556-2017
Medical
equipment
label,marking 		General
Requirements 		  Medical devices -Symbols to be usedwith information to be
supplied by themanufacturer -Part 1:Generalrequirements ISO
15223-1:2021
Respiratory
function and
gas analysis
and
measurement
equipment 		Particulate Matter
Emission Testing 		Biocompatibility evaluation of respiratory gas pathways in
medical applications --Part 2:particulate emission testing ISO
18562-2:2017
Volatile Organic
Compound
Emission Testing 		Biocompatibility assessment of respiratory gas pathways in
   medical applications --Part 3:Volatile Organic compound
emission testing (instruments for volatile organic compounds)
(Instruments For
Volatile Organic
Compounds)(Vocs) 		(VOCs)ISO 18562-3:2017
Condensation Of
The LeaversWater
Test 		Biocompatibility_evaluation of respiratory gas pathways for
medical use -Part 4:Testing for leachable condensation ISO
18562-4:2017
Health care
products 		Sterilization Sterilization ofhealth care products -Low temperature steam
andformaldehyde -Requirements fordevelopment,validation and
routinecontrol ofa sterilization process formedical devices ISO
25424:2018

Small-bore
connectors 		All Of Items Small-bore connectors for liquids and gases in healthcare
  applications —Part 7:Connectors for intravascular or
hypodermic applications ISO 80369-7:2021
Small-bore
connectors 		Leakage By
Pressure Decay 		Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Annex B

PositivePressure
Liquid Leakage 		Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Annex C
Subatmospheric-
Pressure Air
Leakage 		Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Annex D
Stress Cracking Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Annex E
Resistance To
Separation From
Axial Load 		Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Annex F
Resistance To
Separation  From 		Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Unscrewing Annex G
Resistance To
OverridingAL ACCF 		Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Annex   H
Disconnection ByED
Unscrewing 		Small-bore connectors for liquids and gases in healthcare
applications-Part 20:Common test methods YY/T 0916.20-2019
Annex I
packing
material 		Decoloration Packaging materials for terminally sterilized medicaldevices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T 0698.10-20094.3.1
Mean quality Packaging materials for terminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T0698.10-20094.3.2
Tensile strength Packaging materials for terminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T 0698.10-20094.3.3
Tear force Packaging materials for terminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T 0698.10-20094.3.4
Lamination factor Packaging materials for terminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T 0698.10-20094.3.5
Bursting strength Packaging materials for terminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T0698.10-20094.3.6
ABursting strengthcC中 Packaging materials forterminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T069810-20094.3.7
Hydrostatic pressure Packaging materials for terminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T 0698.10-20094.3.8
Coating quality Packaging materials for terminally sterilized medical devices-Part
10:Adhesive coated nonwoven materials of polyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T 0698.10-20094.3.9
Stripping Packaging materials for terminally sterilized medicaldevices-Part
10:Adhesive coated nonwoven materials ofpolyolefines for use
   in the manufacture of sealable pouches,reels and lids-
Requirements and test methods YY/T 0698.10-20094.3.11
packing
material 		PH value Paper,board and pulp-Determination of pH of aqueous extracts
GB/T 1545.2-2003
Paper,board and pulp Determiantion of acidity or alkalinity GB/T
1545-2008
Paper,board and pulp-Determination of pH of aqueous extracts
ISO 6588-1:2021
A NATIONAL ACC中
  Paper,board and pulps—Determination of pH of aqueous
extracts—Part 2.Hot extraction ISO 6588-2:2021
          SCHED
Sulfate content 		Paper,board and pulp-Determination ofj water-soluble sulfates
GB/T 2678.6-2023
Paper,board and pulp—Determination of water-soluble ISO
9198-2020
Fluorescence
intensity 		Paper and board--Measurement of brightness (Diff/o-Geometry)
GB/T 7974-2002
Paper,board and pulps—Measurement of diffuse blue reflectance
factor—D65 brightness(Diff/  Geometry,Outdoor daylight
conditions)GB/T 7974-2013
   Paper,board and pulps --Measurement of diffuse blue
reflectance factor --Part 2:Outdoor daylight conditions (D65
brightness)ISO2470-2:2008
Wet rupture
resistance 		Paper and board--Determination of bursting strength after
immersion in water GB/T465.1-2008
Paper and board;Determination of bursting strength after
immersion in water ISO3689:1983
Wet tensile strength Paper and board--Determination of tensile strength after
immersion in water GB/T465.2-2008
Paper and board--Determination of tensile strength after
immersion in water ISO3781:2011
water-absorbing
quality 		Paper and board--Determination of water absorption--Cobb
method GB/T 1540-2002


A      NATIONALACCR
           SCHED



Establishment of
alloeable limits for
leachable substances

EDIT ATION SERVICE FOR CONFORMITY ASSESS M申
ULE    OF    ACCREDITATION    CERTIFICATE



Biological evaluation of medical device--Part 17:Establishment
of alloeable limits for leachable substances GB/T 16886.17-2005
A     NATIONALACCR
          SCHED 		                                                                         申
EDITATION     SERVICE     FOR     CONFORMITY     ASSESSM
ULE    OF    ACCREDITATION    CERTIFICATE
Active Medical
Devices 		Part of parameters Medical electrical equipment -Part 1-1:General requirements for
safety -Collateral standard:Safety requirements for medical
electrical systems GB 9706.15-2008
Active Medical
Devices 		Usability Medical devices-application fo usability engineering to medical
devices YY/T 1474-2016
Active Medical
Devices 		Partial Parameters Medical electrical equipment --Part 1:General requirements for
basic safety and essential performance ANSI/AAMI ES60601-
1:2005/(R)2012  &     A1:2012,     C1:2009/(R)2012  &
A2:2010/(R)2012&A2:2021
A    NATIONALACCR
          SCHED 		                                                                申
EDITATION    SERVICE    FOR    CONFORMITY    ASSESSM
ULE    OF    ACCREDITATION    CERTIFICATE
Active Medical
Devices 		Partial Parameters Medical electrical equipment --Part 1:General requirements for
basic safety and essential performance CAN/CSA-C22.2
NO.60601-1:14(R2022)
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-11:General requirements
for basic safety andessential performance -Collateral Standard:
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
ANSI/AAMI HA60601-1-11:2015&A1:2021
Active  Medical
Devices 		Usability Medical electrical equipment --Part 1-6:General requirements
for basic safety and essential performance -Collateral standard:
Usability EN 60601-1-6:2010+A1:2015+A2:2021
Active Medical
Devices 		All Parameters Medical electrical equipment--Part 2-10:Particular requirements
for the safety of nerve and muscle stimulators EN 60601-1-
9:2008+A1:2013+A2:2020
Active Medical
Devices 		          SCHED
Usability 		Medical devices FPart H:Application of usability engineering to
medical devices EN 62366-1:2015+A1:2020
Active  Medical
Devices 		All Parameters Environmental requirement and test methods for medical
electrical equipment GB/T 14710-2009
Active Medical
Devices 		PartialParameters Medical electrical equipment --Part 1:General requirements for
    basic safety and essential performance IEC 60601-
1:2005+A1:2012
Active Medical
Devices 		Partial Parameters Medical electrical equipment --Part 1:General requirements for
    basic safety and essential performance IEC 60601-
1:2005+A1:2012+A2:2020
ANATIONAL        ACC
            SCHED 		床 E D I T A T I O N  S E R V I C E  F O R  C O N F O R M I T Y A
ULE     OF     ACCREDITATION     CERTIFICATE
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-11:General requirements
for basic safety and essential performance-Collateral Standard:
  Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment EN
60601-1-11:2015+A1:2021
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-11:General requirements
for basic safety and essential performance -Collateral Standard:
  Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment IEC
60601-1-11:2015
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-11:General requirements
for basic safety and essential performance -Collateral Standard:
  Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment IEC
60601-1-11:2015+A1:2020
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-12:General requirements
for basic safety and essential performance -Collateral Standard:
  Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical
services environment EN 60601-1-12:2015+A1:2020
Active Medical
Devices 		All Parameters Medical Electrical Equipment —Part 1-12:General requirements
for basic safety and essential performance—Collateral Standard:
Requirements for medical electrical equipment and medical
electrical systems used in the emergency medical services
environment IEC 60601-1-12:2014
Active Medical
Devices 		A   NATIONAL   ACCR
All Parameters 		Amendment 1-Medical electrical equipment -Part 1-2:General
requirements for basic -safety and essential performance-
CoHlateralAc Standard:ATElectromagneticATdisturbances
Requirements and tests IEC 60601-1-12:2014+A1:2020
Active Medical
Devices 		Usability Medical electrical equipment --Part 1-6:General requirements
for basic safety and essential performance -Collateral standard:
Usability IEC 60601-1-6:2010+A1:2013+A2:2020
Active Medical
Devices 		All Parameters Medical electrical equipment --Part 1-8:General requirements
for basic safety and essential performance-Collateral Standard:
General requirements,tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems IEC
60601-1-8:2006+A1:2012
Active Medical
Devices 		All Parameters Medical electrical equipment --Part 1-8:General requirements
for basic safety and essential performance -Collateral Standard:
General requirements,tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems IEC
60601-1-8:2006+A1:2012+A2:2020
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-9:General requirements
forbasic safety and essential performance -Collateral Standard:
Requirements for environmentally conscious design IEC 60601-
1-9:2007+A1:2013+A2:2020
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-9:General requirements
forbasic safety and essential performance -Collateral Standard:
Requirements for environmentally conscious design IEC 60601-
1-9:2007+A1:2013
Active Medical
Devices 		Usability Medical devices -Part 1:Application of usability engineering to
medical devices IEC 62366-1:2015+A1:2020
Active Medical
Devices 		All Parameters ACCR
            SCHED 		Medical electrical equipment --Part 1-8:General requirements
for basic safety and essential performance -Collateral Standard:
General requirements,tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems YY
9706.108-2021
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-11:General requirements
for basic safety and essential performance -Collateral Standard:
  Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment YY
9706.111-2021
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-12:General requirements
for basic safety and essential performance -Collateral Standard:
  Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical
services environment YY9706.112-2021
Active Medical
Devices 		Illuminance For
Medical Optical
Instruments 		    Measuement methods of illuminance for medical optical
instruments YY/T 1146-2016
Active Medical
Devices 		Optical Radiation
Safety Classification 		Measuring methods for optical radiation safety classification of
medical LED equipment YY/T 1534-2017
Active Medical
Devices 		Usability Medical electrical equipment --Part 1-6:General requirements
for basic safety and essential performance -Collateral standard:
Usability YY/T9706.106-2021
Active Medical
Devices 		All Parameters Medical electrical equipment --Part 1-8:General requirements
for basic safety and essential performance -Collateral Standard:
General requirements,tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems EN
60601-1-8:2007+A1:2013+A11:2017+A2:2021
Active Medical
Devices 		All Parameters
A   NATIONAL   ACC 		Medical electrical equipment --Part 1-8:General requirements
for basic safety and essential performance -Collateral Standard:
General requirements,tests andguidance for alarm systems in
medical electrical equipment and medical electrical systems
中ANSI/AAMI/IEC60601 1 8:2006&A1:2013&A2:2021
Active Medical
Devices
          SCHED


Partial Parameters
ULE                      N     CERTIFICATE

Medical electrical equipment --Part 1:General requirements for
    basic safety and essential performance EN 60601-
1:2006+A11:2011+A1:2013+A12:2014+A2:2021
Active Medical
Devices 		All Parameters Medical electrical equipment-Part 1-2:General requirements for
basic safety and essential performance -Collateral Standard:
Electromagnetic disturbances -Requirements and tests
ANSI/AAMI/IEC60601-1-2:2014&A1:2021
Active Medical
Devices 		All Parameters Medical electrical equipment -Part 1-2:General requirements for
basic safety and essential performance -Collateral Standard:
  Electromagnetic disturbances -Requirements and tests
ANSI/AAMI/IEC60601-1-2:2014
Active Medical
Devices 		Radio-Frequency
Disturbance
Characteristics 		Industrial,scientific and medical equipment -Radio-frequency
disturbance characteristics-Limits and methods of measurement
CISPR 11:2015+A1:2016
Ultrasonic
Medical
Diagnostic
And
Monitoring
Equipment 		           SCHED
All Parameters 		Medical electrical equipment -Part 2-37Particular requirements
for the basic safety and essential performanceof ultrasonic
medical diagnostic and monitoring equipment EN 60601-2-
37:2008+A11:2011+A1:2015
Ultrasonic
Medical
Diagnostic
And
Monitoring
Equipment 		All Parameters Medical electrical equipment-Part 2-37:Particular requirements
for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment IEC 60601-2-
37:2007+A1:2015
B Mode
Ultrasonic
Diagnostic
Equipment 		All Parameters B mode ultrasonic diagnostic equipment GB 10152-2009
B Mode
Ultrasonic
Diagnostic
Equipment 		Performance Test Performance testing methods for B-mode ultrasonic diagnostic
equipment with intra-cavity probe YY/T 0906-2013
Ultrasonic
Medical
Diagnostic
And
Monitoring
Equipment 		All Parameters Medical electrical equipment-Part 2-37:Particular requirements
for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment GB 9706.237-
2020
Ultrasonic
Colour Flow
Imaging
Systems 		All Parameters Ultrasonic colour flow imaging systems YY/T 0767-2009
Ultrasound
Transcranial
Doppler
System 		All Parameters Ultrasound transcranial Doppler system YY/T0593-2022
Ultrasound
Bladder
Scanner 		All Parameters General technical requiremetns for ultrasound bladder scanner
YY/T 1476-2016
Ultrasonic
Doppler Fetal
Heartbeat
Detector 		All Parameters Ultrasonic doppler fetal heartbeat detector YY/T0448-2019
B Mode
Ultrasonic
Diagnostic
Equipment 		Performance
Requirements 		Medical ultrasound equipment class series-Part 1:B mode
ultrasound disgnostic equipment YY/T 0162.1-2009
Medical
Ultrasoud
Equipemnt
Thermal And
Mechanical Indices 		Ultrasonics -Field characterization -Test methods for the
determination of thermal and mechanical indices related to
medical diagnostic ultrasonic fields YY/T0642-2022
Output Power Meaurement methods of output power for medical diagnostic
ultrasonic equipments YY/T 1084-2015
Ultrasonics-Power
Measuremen 		Ultrasonics-Power measurement -Radiation force balances and
performance requi GB/T7966-2022
Ultrasonic
colour flow
imaging
systems 		All Parameters Ultrasonic colour flow imaging systems YY/T0767-2023
Medical
Ultrasoud
Equipemnt 		Continuous-Wave
Doppler Systems
Performance Test 		   Ultrasonics -Continuous-wave Doppler systems -Test
procedures YY/T0705-2008
Medical
Ultrasoud
Equipemnt 		Characterization Of
Ultrasonic Fields 		  Ultrasonics -Fields=Guidance for_the measurement and
characterization of ultrasonic fields generated by medical
ultrasonic equipment using hydrophones-in the frequency range
0,5 to 15 MHz YY/T 1088-2007
Medical
Ultrasoud
Equipemnt 		Acoustic Power
And Field
Characteristics 		    Acoustics-High intensity focused ultrasound(HIFU)
measurements of acoustic power and field characteristics GB/T
19890-2005
Medical
Ultrasoud
Equipemnt 		Characterizationof
Medical Ultrasonic
Fields 		    Ultrasonics -Hydrophones -Part 1:Measurement and
characterizationof medical ultrasonic fields up to 40 MHz IEC
62127-1:2007+A1:2013
Medical
Ultrasoud
Equipemnt 		RequirementsFor
The Declaration Of
The Acoustic
Output 		Requirements for the declaration of the acoustic output of
medical diagnostic ultrasonic equipment GB/T 16846-2008
Medical
Ultrasoud
Equipemnt 		Acoustic Output Standard means for the reporting of the acoustic output of
medicaldiagnostic ultrasonic IEC61157:2007+C1:2008+A1:2013
Medical
Ultrasoud
Equipemnt 		The Transmitted
Fields Of Focusing
Ultrasonic
Transducers 		  Acoustic-Definitions and measuremetn methords for the
transmitted fieldsof focusing ultrasonic transducers GB/T 20249-
2006
Medical
Ultrasoud
Equipemnt 		Frequecy Of
Medical Ultrasonic
Equipment And
Probe 		Methods of measuring the frequecy of medical ultrasonic
equipment and probe YY/T 1142-2013

Medical
Ultrasoud
Equipemnt 		Acousitcs_Measure
ment And
Characterisation Of
Ultrasoinc Fields
Acousitcs_measurement and characterisation of ultrasoinc fields
in the frequency range 0.5Mhz to 15MHz-Hydrophone method
GB/T 16540-1996
Medical
Ultrasoud
Equipemnt 		Tehcnical
Requirements ForED
Ultrasonic Doppler
Transducerarameter
S 		Tehcnical requirements and test methods for ultrasonic doppler
transducer YY/T0111-2005
Medical
Ultrasoud
Equipemnt 		Beam Area   Measuring methods for beam area of medical ultrasound
equipment transduce YY/T 1278-2015
Medical
Ultrasoud
Equipemnt 		Environmental
Requirement 		Environmental requirement and test methords for medical
ultrasonic equipment YY/T 1420-20164.2
Medical
Ultrasoud
Equipemnt 		Acoustic Output Standard means for the reporting of the acoustic output of
medical      diagnosticultrasonic   equipment      IEC
61157:2007+A1:2013
Medical
Ultrasoud
Equipemnt 		Characterizationof
Medical Ultrasonic
Fieldsarameters 		    Ultrasonics -Hydrophones -Part 1:Measurement and
characterizationof medical ultrasonic fields up to 40 MHz IEC
62127-1:2022
Medical
Ultrasoud
Equipemnt
Thermal And
Mechanical Indices 		Ultrasonics -Field characterization -Test methods for the
determination of thermal and mechanical indices related to
medical diagnostic ultrasonic fields YY/T 0642-2014
Medical
Ultrasoud
Equipemnt 		Performance Of
Ultrasonic Pulse-
Echo Diagnostic
Equipment 		Methods of measuring the performance of ultrasonic pulse-echo
diagnostic equipment YY/T 0643-2008


A   NATIONAL   ACCR

EDITATION     SERVICE     FOR     CONFORMITY     ASSESSME
Rigid
Endoscope 		 All Parameters Medical Endoscopes—Rigid Endoscope—Part 1:Optical
properties and test methods YY 0068.1-2008
Rigid
Endoscope 		 All Parameters Medical endoscopes—Rigid endoscope—Part 2:Mechanical
properties and test methods YY/T 0068.2-2008
Rigid
Endoscope 		 All Parameters Medical endoscopes—Rigid endoscope—Part 3:Marking and
instruction manual YY/T0068.3-2008
Rigid
Endoscope 		 Partial Parameters Medical endoscopes—Rigid endoscope—Part 4:Fundamental
requirement YY 0068.4-2009
Rigid
Bronchoscopes 		 All Parameters particular requirements for rigid bronchoscopes YY/T0069-2009
LaryngoScopic
Fittings 		 All Parameters Laryngoscopic fittings—Part 1:Conventional hook-on type
handle-blade fittings YY0498.1-2004
Laryngoscopic
Fittings 		 All Parameters Laryngoscopic fittings—Part 2:Miniature electric lamps—Screw
threads and sockets for conventional blades YY 0498.2-2004
Anaesthetic
Laryngoscope 		 All Parameters General specifications for anaesthetic laryngoscope YY 0499-
2004
Upper Gastro
Intestinal
Fiberscope 		 All Parameters Upper gastro intestinal fiberscope YY/T 1028-2008
Capsule
Endoscopes 		 Partial Parameters Medical endoscopes—Capsule endoscopes YY/T 1298-2016

Esophagoscope 		All Parameters ACC
中Esophagoscope YY/T 0070-2018          ITYASSESSM
Sigmoidoscopy
And
Rectoscopy Set 		           SCHED
All Parameters 		Sigmoidoscopy and rectoscopy set YY/T0071-2018
Arge Intestine
Fiber
Endoscope 		Partial Parameters Large intestine fiber endoscope YY/T 0283-2007
Rigid Resecto
SOcope 		Partial Parameters Medical endoscopes—Rigidresectosocope YY/T 0619-2017
Fibre Optical
Cables For
Lighting 		All Parameters Medical endoscopes—Fibre optical cables for lighting YY/T
0763-2009
Sheaths All Parameters Medical endoscopes—Endoscope accessories—Sheaths YY/T
0842-2011
Endoscope
Functional
Supply Units—
Roller
IrrigationAnd
Suction
Equipment 		Partial Parameters Medical endoscopes—Endoscope functional supply units—Roller
irrigation and suction equipment YY/T 0863-2011
Endoscope
Functional 		Partial Parameters Medical endoscopes—Endoscope functional supply units—
Irrigation pump YY/T0864-2011
Supply Units—
Irrigation
Pump
Video
Endoscopes 		A   NATIONAL   ACCF
Partial Parameters 		        1ON      SERVICE      FOR      CONFORMITYASSESSMF
Medical endoscopes—Video endoscopes YY/T1587-2018
Endoscopes
And
Endotherapy
Devices 		All Parameters Optics and optical instruments-Medical endoscopes and
endoscopic accessories Part 2:Particular requirements for rigid
bronchoscopes ISO8600-2:2015
Endoscopes
And
Endotherapy
Devices 		All Parameters Endoscopes-Medical endoscopes and endotherapy devices-Part
7:Basic requirements for medical endoscopes of water-resistant
type ISO 8600-7:2012
Fiberoptic
endoscopes 		All parameters Medical endoscopes Fiberoptic endoscopes YY/T 1028-2023
Endoscope
surgical
equipment-
Shaver 		Partial Parameters Medicalendoscopes_Endoscope surgical equipment-Shaver YY/T
0955-2014
anaesthetic
laryngoscope 		All Parameters General specifications for anaesthetic laryngoscope YY 0499-
2023
endoscopes
and
endotherapy
devices 		Partof Parameters endoscopes and endotherapy devices ISO8600-1:2015
General
Purpose Metric 		Basic Dimensions General purpose metric screw threads-basic dimensions GB/T
196-2003
Equipemnt Ultrasonic Elasticity
Imaging Equipment
Based On Acoustic
Radiation Force 		equipment based on acoustic radiation force YY/T 1480-2016
Ultrasoud
Equipemnt 		Definitions
Regarding
Focsusing For The
Transmitted Fields
    Ultrasonics-Transducers -Definitions and measurement
  methodsregarding focsusing for the transmitted fields IEC
61828:2020
Ultrasoud
Equipemnt
Acousitcs_Measure
ment And
Characterisation Of
Ultrasoinc Fields 		Acousitcs_measurement and characterisation of ultrasoinc fields
  in the frequency range 0.5Mhz to 15MHz-Hydrophone method
IEC61102:1991+A1:1993
Ultrasonics-
Surgical
Systems 		Primary tip
vibration excursion 		Ultrasomics-surgical—Measurement and declaration of the basic
output characteristics EN 61847:19986.1
Secondary tip
vibration excursion 		Ultrasomics-surgical—Measurement and declaration of the basic
output characteristics EN 61847:19986.2
Drive frequency Ultrasomics-surgical—Measurement and declaration of the basic
output characteristics EN 61847:19986.3
Tip vibration
frequency 		Ultrasomics-surgical—Measurement and declaration of the basic
output characteristics EN 61847:19986.4
Derived output
acoustic power and
outputacoustic
power 		Ultrasomics-surgical—Measurement and declaration of the basic
output characteristics EN 61847:19986.5
Directivity pattern Ultrasomics-surgical—Measurement and declaration of the basic
output characteristics EN 61847:19986.6
Primary tip
vibration
excursionmodulatio 		Ultrasomics-surgical—Measurement and declaration of the basic
outputcharacteristics EN 61847:19986.7
Monitoring
Equipment 		A   NATIONAL   ACC
          SCHED 		pressure monitoring equipment YY 0783-2010

床EDIT ATION SERVICE FOR CONFORMITY A
ULE    OF    ACCREDITATION    CERTIFICATE
Multifunction
Patient
Monitoring
Equipment 		Partial Parameters Medical electrical equipment -Part 2-49:Particular requirements
for the basic safety and essential performance ofmultifunction
patient monitoringequipment EN IEC 80601-2-49:2019
Multifunction
Patient
Monitoring
Equipment 		Partial Parameters Medical electrical equipment -Part 2-49:Particular requirements
for the basic safety and essential performance of multifunction
patient monitoring equipment IEC80601-2-49:2018
and controllers A      NATIONALACCR
          SCHED 		for the basic safety and essential performance of infusion pumps
and controllers GB 9706.224-2021
EDITATION      SERVICE      FOR      CONFORMITYASSESSME
ULE    OF    ACCREDITATION    CERTIFICATE

Infusion pumps
and controllers 		All Parameters Medical electrical equipment-Part 2-24:Particular requirements
for the basic safety and essential performance of infusion pumps
and controllers IEC 60601-2-24:2012

Infusion pumps
and controllers 		All Parameters Medical electrical equipment -Part 2-24:Particular requirements
for the basic safety and essential performance of infusion pumps
and controllersEN 60601-2-24:2015
Screening
Thermographs
For Human
Febrile
Temperature
Screening 		All Parameters Medical electrical equipment -Part 2-59:Particular requirements
for the basic safety and essential performance of screening
thermographs for human febrile temperature screening EN IEC
80601-2-59:2019
Screening
Thermographs
For Human
Febrile
Temperature
Screening 		All Parameters Medical electrical equipment -Part 2-59:Particular requirements
for the basic safety and essential performance of screening
thermographs for human febrile temperature screening IEC
80601-2-59:2017
Ecg Cables
And Leadwires 		All Parameters ECG   TRUNK   CABLES   and   PATIENT   LEADWIRES
ANSI/AAMI EC53:2013/(R)2020
EcgCables
And Leadwires 		All Parameters ECG cables and leadwires YY0828-2011
Electrocardiogr
aphs 		All ParametersCHED Medical electricat equipment -Part 2-25:Particular requirements
  forE theAbasicE safetynicandEessentialA performance of
electrocardiographs ANSI/AAMI/IEC 60601-2-25:2011(R2016)
Electrocardiogr
aphs 		All Parameters Medical electrical equipment -Part 2-25:Particular requirements
    for the basic safety and essential performance of
electrocardiographs EN 60601-2-25:2015
Electrocardiogr
aphs 		All Parameters Medical electrical equipment -Part 2-25:Particular requirements
for the basic safety and essential      performance of
electrocardiographs IEC 60601-2-25:2011
Ambulatory
Electrocardiogr
aphic Systems 		All Parameters Medical electrical equipment-Part 2-47:Particular requirements
for the basic safety and essential performance of ambulatory
   electrocardiographic systems ANSI/AAMI/IEC 60601-2-
47:2012(R2016
Ambulatory
Electrocardiogr
aphic Systems 		All Parameters Medical electrical equipment -Part 2-47:Particular requirements
for the basic safety and essential performance of ambulatory
electrocardiographic systems EN 60601-2-47:2015
Ambulatory
Electrocardiogr
aphic Systems 		All Parameters Medical electrical equipment -Part 2-47:Particular requirements
for the basic safety and essential performance of ambulatory
electrocardiographic systems IEC60601-2-47:2012
Electronic
Thermometer
For
Intermittent
Determination
OfPatient
Temperature 		All Parameters   Standard Specification for Electronic Thermometer for
Intermittent determination of Patient temperature ASTM E1112-
00(2018)
Infrared
Thermometer 		All Parameters Standard Specification forlnfrared Thermometers for Intermittent
Determination ofPatient Temperature ASTM E1965-98(2023)
Clinical
Thermometer
APartialParametersC
            SCHED 		    Medical electrical equipment --Part 2-56:Particular requirements
for  the_basic  safety  and  essential  performance  of  colinical
中
thermometers   for   body   temperature   measurement   ENTSO80601-
2-56:2017+A12020
Clinical
Thermometer 		All Parameters Medical electrical equipment --Part 2-56:Particular requirements
for the basic safety and essential performance of colinical
thermometers for body temperature measurement ISO 80601-2-
56:2017+A1:2018
Clinical
Thermometer 		Partial Parameters Clinical thermometers-Performacne of electrical thermometers
for continuous measurement YY0785-2010
clinical
thermometers 		Partial parameters Medical electrical equipment--Part 2-56:Particular requirements
for the basic safety and essential performance of colinical
  thermometers for body temperature measurement YY9706.256-
2023
Pulse Oximeter
Equipment 		Partial Parameters Medical electrical equipment--Part 2-61:Particular requirements
for basic safety and essential performance of pulse oximeter
equipment EN ISO 80601-2-61:2019
Electrocardiogr
aphs 		Partial Parameters Medical electrical equipment—Part 2-25:Particular requirements
    for the basic safety and essential performance of
electrocardiographs GB 9706.225-2021

Clinical
Electronic
Thermometer 		Partial Parameters Clinical electronic thermometer GB/T21416-2008

Clinical
Infrared
Thermometers 		Partial Parameters Clinical infrared thermometers——Part 1:Ear GB/T 21417.1-
2008
Automated
Non-Invasive
Sphygmomano
meters 		Partial Parameters Medical electrical equipment -Part 2-30:Particular requirements
for the basic safety and essential performance of automated non-
invasive sphygmomanometers IEC80601-2-30:2009+A1:2013

Automated
Non-Invasive
Sphygmomano
meters 		Partial Parameters Medical electrical equipment-Part 2-30:Particular requirements
for the basic safety and essential performance of automated non-
invasive sphygmomanometers IEC80601-2-30:2018
A      NATIONALACCR
           SCHE 		EDIT ATION SERVICE FOR CONFORMITY ASSESS M申
               EOFACCREDTATONCERT
Automated
Non-Invasive
Sphygmomano
meters 		Partial Parameters Medical electrical equipment-Part 2-30:Particular requirements
for the safety,inculding essential performance,of automatic
cycling non-invasiver blood pressure monitoring equipment YY
0667-2008
Automated
Non-Invasive
Sphygmomano
meters 		Partial Parameters Medical electrical equipment-Part 2-30:Particular requirements
for the basic safety and essential performance of automated non-
invasive sphygmomanometers YY9706.230-2023
Non-Invasive
Sphygmomano
meters 		All Parameters Non-invasive sphygmomanometers --Part 1:Requirements and
test methods for non-automated measurement type EN ISO
81060-1:2012


A NATIONAL ACCR
        SCHED

EDITATION      SERVICE     FOR     CONFORMITYASS
ULE    OF    ACCREDITATION    CERTIFICATE
Home
Healthcare
Environment
Ventilators For
Ventilator-
Dependent
Patients 		All Parameters Medical electrical equipment -Part 2-72:Particular requirements
for basic safety and essential performance of home healthcare
environment ventilators for ventilator -dependent patients YY
9706.272-2021
Respiratory
Humidifying
Equipment 		Part Of Parameters
A
            SCHED
Medical electrical equipment-Part 2-74:           Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment YY9706.274-2022
UL                                  TIFICATE
Emergency
And Transport
Ventilators 		All Parameters Lung ventilators for medical use-Particular requirements for basic
safety and essential performance-Part 3:Emergency and transport
ventilators YY 0600.3-2007
Critical care
ventilators 		Part of Parameters      Medical electrical equipment —Part 2-12:Particular
requirements for basic safety and essential performance of critical
care ventilators ISO 80601-2-12:2023
Emergency
And Transport
Ventilators 		Part of Parameters Medical electrical equipment-Part 2-84:Particular requirements
for the basic safety and essential performance of ventilators for
   the emergency medical services environment ISO 80601-2-
84:2023

Critical care
ventilators 		All Parameters      Medical electrical equipment —Part 2-12:Particular
requirements for basic safety and essential performance of critical
care ventilators GB 9706.212-2020
Home-Care
Ventilator
Support 		All Parameters Medical electrical equipment -Part 2-72:Particular requirements
for basic safety and essential performance of home healthcare
environment ventilators for ventilator -dependent patients ISO
Devices 80601-2-72:2023
Home
Healthcare
Environment
Ventilators For
Ventilator -
Dependent
Patients 		A   NATIONAL   ACCF
All Parameters 		Eung ventlatorsfoF medieaF use-Particular requirements for basic
safety and essential performance-Part-2 Home care ventilators
for ventilator-dependent patients YY 0600.2-2007
Sleep apnea
treatment
equipment 		Part of Parameters Sleep apnoea breathing therapy—Part 1:Sleep apnoea breathing
therapy devices YY 0671.1-2009
Sleep apnea
treatment
equipment 		All Parameters Medical electrical equipment-Part 2-70:Particular requirements
for basic safety and essential performance of sleep apnoea
breathing therapy equipment YY 9706.270-2021
Sleep apnea
treatment
equipment 		Part of Parameters Medical electrical equipment-Part 2-70:Particular requirements
for basic safety and essential performance of sleep apnoea
breathing therapy equipment ISO80601-2-70:2020
Resuscitators All Parameters Lung ventilators for medical use—Particular requirements for
basic safety and essential performance—Part 4:operator-powered
resuscitators YY0600.4-2013
Resuscitators All Parameters Lung ventilators for medical use—Particular requirements for
basic safety and essential performance—Part 5:Gas-powered
Equipmen NATIONALACCR
SCHED 		EDIT ATION SERVICE FOR CONFORMITY ASSESS M申
ULE    OF    ACCREDITATION    CERTIFICATE
Anaesthetic
And
Respiratory
Equipmen 		  of Parameters Medical electrical equipment-Part 2-90:Particular requirements
for basic safety and essential performance of respiratory high
flow therapy equipment ISO80601-2-90:2021
Respiratory gas
monitors 		  of Parameters Medical electrical equipment—Part 2-55:Particular requirements
for the basic safety and essential performance of respiratory gas
monitors GB 9706.255-2022
Respiratory gas
monitors 		  ofParameters Medical electrical equipment—Part 2-55:Particular requirements
for the basic safety and essential performance ofrespiratory gas
monitors ISO80601-2-55:2018
Oxygen
Supplies For
Medicine And
Aircraft
Breathing
All Of Items
A   NATIONAL   ACCF
Oxygen supplies for medicine and aircraft breathing GB/T 8982-
2009
REDITATION      SERVICE      FOR      CONFORMITYASSESSM
Oxygen
Supplies For
MedicineAnd
Aircraft
Breathing 		Carbon Monoxide,EC
Carbon Dioxide,
Total Hydrocarbon
Content 		   Determination of carbon monoxide carbon dioxide and
hydrocarbon in gases--Gas chromatographic method GB/T 8984-
2008
Oxygen
Concentrator
Equipment 		Partial Parameters   Medical electrical equipment—  Part 2-69:  Particular
requirements for basic safety and essential performance of
oxygen concentrator equipment EN ISO 80601-2-69:2020
Oxygen
Concentrator
Equipment 		Partial Parameters Medical electrical  equipment —  Part 2-69:  Particular
requirements for basic safety and essential performance of
oxygen concentrator equipment ISO 80601-2-69:2020
Oxygen
Concentrator
Equipment 		Partial Parameters    Medical electrical equipment—  Part 2-69:Particular
requirements for basic safety and essential performance of
oxygen concentrator equipment YY9706.269-2021
Nebulizing
Systems And
Components 		Part Of Items Anaesthetic and respipment-Nebulizing systemsand components
ISO 27427:2023
Nebulizing
Systems And
Components 		Part Of Items Anaesthetic and respipment-Nebulizing systems and components
YY/T 1743-2021
Anesthetic
Storage
Balloon 		All Of Items Anaesthetic reservoir bags ISO5362:2006
Anesthetic
Storage
Balloon 		All Of Items Anaesthetic reservoir bags YY/T0978-2016           SSM
Moisture
Exchangers
(Hmes) 		All Of Items Anaesthetic and respiratory equipment-Heat and moisture
exchangers(HMEs)for humidifying respired gases in humans
Part 1:HMEs for use with minimum tidal volumes of250 mL ISO
9360-1:2000
Moisture
Exchangers
(Hmes) 		All Of Items Anaesthetic and respiratory equipment-Heat and moisture
   exchangers  (HMEs)for humidifying respired gases in
humans-Part 2:HMEs for use with tracheostomized patients
having minimum tidal volumes of 250 mL ISO 9360-2:2001
Moisture
Exchangers
(Hmes) 		All Of Items Anaesthetic and respiratory equipment-Heat and moisture
exchangers(HMEs)for humidifying respired gases in humans
Part 1:HMEs for use with minimum tidal volumes of 250 mL
YY/T 0735.1-2009
Moisture
Exchangers
(Hmes) 		All Of Items Anaesthetic and respiratory equipment-Heat and moisture
   exchangers  (HMEs)for humidifying respired gases in
humans-Part 2:HMEs for use with tracheostomized patients
  having minimum tidal volumes of 250 mL YY/T0735.2-2010
Oxygen
humidifiers 		Part Of Items Anaesthetic and respiratory equipment-Oxygen humidifiers for
medical use YY/T 1610-2018
Medical
Ultrasonic
Nebulizer 		All Parameters medical ultrasonic nebulizer YY/T0109-2013
Conical
connectors 		All Of Items Anaesthetic and respiratory equipment-Conical connectors-Part2
Screw-threaded weight-bearing connectors YY/T 1040.2-2008
Respiratory
filters
Filtering
PerformanceL ACCF 		Breathing system filters for anaesthetic and respiratory use-Part
1:Salt test method to assess filtration performance ISO 23328-
1:2003
Non-FiltrationCHED
Aspects 		Breathing system filters for anaesthetic and respiratory use-Part 2
:Non-filtration aspects ISO23328-2:2002
Mask Part Of Items Sleep apnoea breathing therapy Part 2:Masks and application
accessories ISO 17510:2015
Mask Part Of Items Sleep apnoea breathing therapy Part 2:Masks and application
accessories YY/T0671-2021
Cones And
Sockets 		All Of Items Anaesthetic and respiratory equipment-Conical connectors-Part
1:Cones and sockets ISO5356-1:2015

ConesAnd
Sockets 		All Of Items Anaesthetic and respiratory equipment-Conical connectors-Part 2
     :Screw-threaded weight-bearing connectors ISO 5356-
2:2012+A1:2019
Cones And
Sockets 		All Of Items Anaesthetic and respiratory equipment-Conical connectors-Part
1:Cones and sockets YY/T 1040.1-2015
Tubes and
Connectors 		All Of Items Anaesthetic and respiratory equipment -Tracheal tubes and
connectors ISO 5361:2023
Oropharyngeal
Airways 		All Of Items Anaesthetic and respiratory equipment-Oropharyngeal airways
ISO 5364:2016
Breathing sets
and connectors 		All Of Items breathing tubes intended for use with anaesthetic apparatus and
ventilators ISO5367:2023
Suction
catheters 		All Of Items Suction catheters for use in the respiratory tract ISO8836:2019
Tubes and
Connectors 		All Of Items Tracheal tubes Part 1:commonly-used tubes and connectors YY/T
0337.1-2002
Tube All Of Items Tracheal tubes-Part 2:Cole type tube YY/T 0337.2-2002
Tubes and
Connectors 		All Of Items Tracheostomy tubes-Part4:Tubes and connectors for adults YY/T
0338.1-2002
Tube All Of Items Tracheostomy tubes-Part 2:Paediatric tracheostomy tubes YY/T
0338.2-2002
Breathing
tubes 		All Of Items breathing tubes intended for use with anaesthetic apparatus and
ventilators YY/T0461-2003

Rectal
catheters 		Part Of Items Sterile rectal catheters for single use YY/T0488-2004

Ablation
catheter 		Part Of Items Radio frequency ablation catheter YY0778-2018
Suction
catheters 		All Of Items Suction catheters for use in the respiratory tract YY/T0339-2019
Oropharyngeal
Airways 		All Of Items Anaesthetic and respiratory equipment-Oropharyngeal airways
YY/T0977-2016
Buoy Type
Oxygen
Inhalator 		All Of Items Buoy type oxygen inhalator YY1107-2003
Nasal Oxygen
Cannula 		Part Of Items Nasal oxygen cannula YY/T1543-2017
tube assembly All parameters Anaesthetic and respiratory equipment—Compatibility with
oxygen ISO 15001:2010
tube assembly All parameters Anaesthetic and respiratory equipment—Compatibility with
oxygen YY/T 0882-2013
tube assembly All Parameters   Anaesthetic and respiratoryequipment —Low-pressure hose
assemblies for use with medical gases ISO 5359:2014
tube assembly All Parameters Low-pressure hose assemblies for use with medical gases YY/T
0799-2010
tube assembly All ParametersCHED Terminal units for medical gas pipeline systems-Part I:Terminal
units for use with compressed medicat gases andvacuum YY/T
0801.1-2010
tube assembly All Parameters Terminal units for medical gas pipeline systems-Part 2:Terminal
units for anaesthetic gas scavenging systems YY0801.2-2010
tube assembly All Parameters Terminal units for medical gas pipeline systems-Part 1:Terminal
units for use with compressed medical gases and vacuum ISO
9170-1:2017
tube assembly All Parameters Terminal units for medical gas pipeline systems-Part 2:Terminal
units for anaesthetic gas scavenging systems ISO 9170-2:2008
Breathing sets
and connectors 		All Parameters Anaesthetic and respiratory equipment —Breathing sets and
connectors ISO5367:2014
tube assembly All Parameters Respiratory therapy equipment —Part 2:Tubing and connectors
BS EN 13544-2:2002
Tube
Assembly 		Determination of
electrical resistance 		Rubber,vulcanized or thermoplastic—Antistatic and conductive
products—Determination of electrical resistance GB/T 11210-
2014
Rubber,vulcanized or thermoplastic—Antistatic and conductive
products—Determination of electrical resistance ISO2878:2017
tube assembly All Parameters Gas mixers for medical use -Standalone gas mixers YY/T 0893-
2023
Oropharyngeal
Airways 		All Of Items Anaesthetic and respiratory equipment-Oropharyngeal airways
YY/T 0977-2023
tubes and
connectors 		All Of Items Tracheostomy tubes and connectors YY/T 0338-2023
Anaesthetic
and respiratory
equipment 		All    OfltemssCHED Anaesthetic and respiratory equipment-General requirementsfor
airways and related equipment ISO 18190:2016
Trachea All Of Items Anaesthetic and respiratory equipment-General requirements for
airways and related equipment YY/T 1844-2022
Anaesthetic
and respiratory
equipment 		All Of Items   Anaesthetic and respiratory equipment-Tracheostomy tubes
andconnectors ISO5366:2016
Ultrasonic
Physiotherapy
Equipment 		Field Specifications Ultrasonic-Physiotherapysystems -Field specifications and
methords of measurement in the frequency range 0.5 MHz to 5
MHz YY/T 0750-2018
Ultrasonic
Physiotherapy
Equipment 		Sound Field
Requirements 		Ultrasound physiotherapy equipment Sound field requirements
and  measurement  methods  in  the  frequency  range  of
0.5MHz~5MHz      IEC61689:2022
Ultrasonic
Physiotherapy
Equipment 		All Parameters Part 2-5:Particular requirements for the basicsafety and essential
performance of ultrasonicphysiotherapy equipment EN 60601-2-
5:2015
Ultrasonic
Physiotherapy
Equipment 		All Parameters Part 2-5:Particular requirements for the basicsafety and essential
performance of ultrasonicphysiotherapy equipment GB9706.205-
2020
Ultrasonic
Physiotherapy
Equipment 		All Parameters Medical electrical equipment Part 2-5:Paticular requirement for
the safety of ultrasonic physiotherapy equipment IEC 60601-2-
5:2009
Ultrasonic
Physiotherapy
Equipment 		All Parameters Ultrasonic physiotherapy equipment YY/T 1090-2018
Ultrasonic
Therapy
Equipment For
Superficial
Tissue
A     NATIONALACCR
        PaTaTmeters
EDITATION     SERVICE     FOR     CONFORMITY     ASSESSM
Ultrasonic therapy equipment for_superficial tissue YY 0830-
HED20日
Ultrasonic
Physiotherapy
Equipment 		Rated output power Ultrasonics—Physiotherapy systems—Field specifications and
methods of measurement in the frequency range 0.5MHzto5MHz
EN IEC61689:20228.2
Effective radiating
area 		Ultrasonics—Physiotherapy systems—Field specifications and
methods of measurement in the frequency range 0.5MHzto5MHz
EN IEC61689:20228.3
Beam non-
uniformity ratio 		Ultrasonics—Physiotherapy systems—Field specifications and
methods of measurement in the frequency range 0.5MHzto5MHz
EN IEC61689:20228.4
Effective intensity Ultrasonics—Physiotherapy systems—Field specifications and
methods of measurement in the frequency range0.5MHzto5MHz
EN IEC61689:20228.5
Electrodes For
Nerve And
Muscle
Stimulators 		Part Of Items Electrodes for nerve and muscle stimulators YY/T0868-2021

Nerve And
Muscle
Stimulators 		Measurement Of
Effective  Values 		Test method for measuring output characteristics of nerve and
muscle stimulators YY/T 0696-20215.1
Current Density Test method for measuring output characteristics of nerve and
muscle stimulators YY/T 0696-20215.2
Pulse Energy Test method for measuring output characteristics of nerve and
muscle stimulators YY/T 0696-20215.3
Pulse Width Test method for measuring output characteristics of nerve and
muscle stimulators YY/T 0696-20215.4
Pulse Repetition
Rate 		Test method for measuring output characteristics of nerve and
muscle stimulators YY/T0696-20215.5
Dc Component Test method for measuring output characteristics of nerve and
muscle stimulators YY/T 0696-20215.6
Nerve And
Muscle
Stimulators 		All Parameters Medical electrical equipment -Part 2-10:Particular requirements
for the basic safety and essential performance of nerve and
muscle stimulators EN 60601-2-10:2015+A1:2016
Nerve And
Muscle
Stimulators 		All Parameters Medical electrical equipment -Part 2-10:Particular requirements
for the basic safety and essential performance of nerve and
muscle stimulators IEC60601-2-10:2012+A1:2016
Nerve And
Muscle
Stimulators 		All Parameters Medical electrical equipment -Part 2-10:Particular requirements
for the basic safety and essential performance of nerve and
muscle stimulators YY9706.210-2021
Nerve And
Muscle
Stimulators 		All Parameters Medical electrical equipment-Part 2-10:Particular requirements
for the basic safety and essential performance of nerve and
muscle stimulators IEC 60601-2-10:2012+A1:2016+A2:2023
Diagnostic
And
Therapeutic
Laser
Equipment 		All Parameters Medical electrical equipment -Part 2-22:Particular requirements
for basic safety and essential performance of surgical,cosmetic,
therapeutic and diagnostic laser equipment EN IEC 60601-2-
22:2020
Diagnostic
And
Therapeutic 		All Parameters Medical electrical equipment-Part 2-22:Particular requirements
for basic safety and essential performance of surgical,cosmetic,
therapeutic and diagnostic laser equipment IEC 60601-2-22:2019
Laser
Equipment
Non-Laser
Light Source 		All ParametersACC Medical electricalequipment-Part 2-57:Particular requirements
for the basic safety and essential performance of non-laser light
R
sourceequipment intended for therapeutic,diagnostic,monitoring
and cosmetic/aesthetic use EN 60601-2-57:2011E
Non-Laser
Light Source 		All Parameters Medical electrical equipment -Part 2-57:Particular requirements
for the basic safety and essential performance of non-laser light
source equipment intended for therapeutic,diagnostic,monitoring
and cosmetic/aesthetic use IEC 60601-2-57:2011
Home Light
Therapy
Equipment 		All Parameters Medical electrical equipment-Part 2-83:Particual requirements
fot the basic safety and essentical performance of home light
therapy equipment EN IEC 60601-2-83:2020+A11:2021
He-Ne Laser
Medical
Requiremnet 		All Parameters General sepcification of He-Ne laser medical requiremnet GB
12257-2000
Surgical,Cosm
etic,Therapeuti
c And
Diagnostic
Laser
Equipment 		All Parameters Medical electrical equipment-Part 2-22:Particular requirements
for basic safety and essential performance of surgical,cosmetic,
therapeutic and diagnostic laser equipment GB 9706.222-2022
Surgical,Cosm
etic,Therapeuti
cAnd
Diagnostic
Laser
Equipment 		All of parameters Medical electrical equipment --Part 2:Particular requirements
for the safety of diagnostic and therapeutic laser equipment GB
9706.20-2000
Infant
Phototherapy 		All Parameters Medical electrical equipment -Part 2-50:Particular requirements
for the basic safety and essential performance of infant
Equipment phototherapy equipment IEC60601-2-50:2020
Infant
Phototherapy
Equipment 		 All Parameters Medical electrical equipment-Part 2-50:Particular requirements
for the_basic safety and essential performance of infant
phototherapy equipment YY9706.250-2021
Home Light
Therapy
Equipment 		           SCHED
 All Parameters 		Medical electrical equipment-Part 2-83:FParticual requirements
fot the basic safety and essentical performance of home light
therapy equipment IEC 60601-2-83:2019+A1:2022
Home Light
Therapy
Equipment 		 All Parameters Medical electrical equipment-Part 2-83:Particual requirements
fot the basic safety and essentical performance of home light
therapy equipment GB 9706.283-2022
Heat Radiation
Therapy
Equipment 		 All Parameters Particular requipments for the safety of heat radiation therapy
equipment YY 0306-2018
Infrared
Therapy
Equipment 		 All Parameters Particular requrements for the safety of infrared therapy
equipement YY0323-2018
Diode Laser
Equipment For
Photodynamic
Therapy 		 All Parameters   Laser therapeutic equipment-Diode laser equipment for
photodynamic therapy YY 0845-2011
Ho:Yag Laser
Equipment 		 All Parameters   Laser therapeutic equipment-Ho:YAG laser equipment YY
0846-2011
Ultraviolet
Therapy
Equipment 		 All Parameters Ultraviolet therapy equipment YY/T 0901-2013
Therapeutic
Laser
Equipment-
Ruby Laser 		 All Parameters Therapeutic laser equipment-Ruby laser equipment for therapy
YY0983-2016
Equipment-
Ophthalmic
Semiconductor
Laser
Photocoagulato
rs

A       NATIONALACC 		instrument YY1289-2022

床EDIT ATION SERVICE FOR CONFORMITY ASSESS M
Non-Laser
Light Source
Equipment 		All parameters Application of GB/T 20145 for the assessment of blue light
hazardto light sources and luminaires GB/Z 39942-2021
Infant
Phototherapy
Equipment 		All parameters Medical electrical equipment-Part 2-50:Particular requirements
for the basic safety and essential performance of infant
phototherapy equipment EN IEC60601-2-50:2021
non-laser light
source 		All Parameters    Medical electrical equipment -Part 2-57:Particular
requirements for the basic safety and essential performance of
non-laser light source equipment intended for therapeutic,
diagnostic,monitoring,cosmetic and aesthetic use IEC 60601-2-
57:2023
Heat radiation
therapy
equipment 		All Parameters Particular requipments for the safety of heat radiation therapy
equipment YY 0306-2023
Laser diode
irradiation
therapeutic
equipment  for
nasal cavity 		Partial Parameters Therapeutic laser equipment-Laser diode irradiation therapeutic
equipment for nasal cavity YY/T 1751-2020
He-Ne laser
medical
requiremnet 		All Parameters Laser therapeutic equipment-He-Ne laser equipment GB/T
12257-2023
infant
phototherapy 		All Parameters Medical electrical equipment -Part 2-50:Particular requirements
for the basic safety and essential performance of infant
Blankets,Pads
And Similar
Flexible
Heating
Appliances
A    NATIONAL    ACC
            SCHED
Partial Parameters
REDITATION      SERVICE      FOR      CONFORM
MedicaF electricaF equipment-Part 2-351FParticular requirements
for the basic safety and essential performance of heating devices
using blankets ,pads or mattresses and intended for heating in
medical use YY9706.235-2021
Medical
Heaating Pad
Therapy
Equipment 		All Parameters Medical heaating pad therapy equipment YY/T 0165-2016
Hemodialysis
apparatus 		All Of Items Preparation and quality management of fluids for haemodialysis
and related therapies —Part 4:Concentrates for haemodialysis
and related therapies ISO 23500-4:2019
Peritoneal
Dialysis
Apparatus 		All Of Items Peritoneal dialysis catheters YY/T 0030-2004
Peritoneal
Dialysis
Apparatus 		Part Of Items Packaging materials for haemodialysis and related therapeutic
concentrates-General requirements YY/T1494-2016
Peritoneal
Dialysis
Apparatus 		Part Of Items Iodine liquid protective cap for peritoneal dialysis YY/T 1734-
2020
Peritoneal
Dialysis
Apparatus 		            SCHED
PartOf ltems 		Disposable drainage system for peritoneal dialysis YY/T 1760-
2021
Peritoneal
Dialysis
Apparatus 		Part Of Items Disposable transfer line for peritoneal dialysis YY/T 1773-2021
Hemodialysis
Apparatus 		Part Of Items Responsive image Responsive imageHemodialysis         and          relevant
Haemodialysers,haemodiafilters,haemofilters
haemoconcentrators YY 0053-2016
Hemodialysis
Apparatus 		All Of Items Concentrates for haemodialysis and related therapies YY 0598-
2015
Hemodialysis
Apparatus 		Partial Parameters Medical electrical equipment-Part 2-39:Particular requirements
for basic safety and essential performance of peritoneal dialysis
equipment EN IEC60601-2-39:2019
Hemodialysis
Apparatus 		Partial Parameters Medical electrical equipment—Part 2-39:Particular requirements
for basic safety and essential performance of peritoneal dialysis
A   NATIONAL   ACCR
          SCHED 		equipment GB 9706.239-2021

EDITATION     SERVICE     FOR     CONFORMITYA
ULE    OF    ACCREDITATION    CERTIFICATE
Hemodialysis
Apparatus 		All Parameters Medical electrical equipment—Part 2-39:Particular requirements
for basic safety and essential performance of peritoneal dialysis
equipment IEC60601-2-39:2018
Blood
Purification
Aids 		Part Of Items Hemodialysis and related therapies-Extracorporeal blood circuit
for blood purification devices YY0267-2016
Blood
Purification
Aids 		Part Of Items Disposable membrane pl asmaseparator and pl asma component
separator YY0465-2019
Blood
Purification
Aids 		Part Of Items Blood components separation sets for single use,centrifuge
bowl type YY 0584-2005
Blood
Purification
Aids 		Part Of Items Blood components separation sets for single use ,centrifuge bag
type YY 0613-2007
Blood
Purification
Aids 		Part Of Items Dialysis fluid filter YY/T 1272-2016
Blood
Purification
Aids 		Part Of Items Plasmapheresis centrifuge apparatus for single use YY/T 0326-
2017TATION      SERVICE      FOR      CONFORMITYASSESSM
Blood
Purification
Aids 		           SCHED
Part Of Items 		ULE    OF    ACCREDITATION    CERTIFICATE
Hemodialysis catheter for single use YY/T 1730-2020
Hemoperfusion
Apparatus 		Part Of Items Disposable hemoperfutor YY/T 0464-2019
Storage Blood
Filter 		Part Of Items Human blood containers for UV rays transmission therapy for
single use YY 0327-2002
Storage Blood
Filter 		Part Of Items Autologous blood processing devices for single use——Part 1:
Blood cell recoery sets,centrifuge bowl type YY/T 1566.1-2017
Responsive imageCardiopulmona
ry bypass
systems-
Suction 		Part Of Items Cardiopulmonary bypass systems-Suction catheter for single use
YY/T 1271-2016
Cardiopulmona
ry bypass
apparatus 		Part Of Items Cardiopulmonary bypass systems—Extracorporeal blood circuit
YY 1048-2016
Blood Bag
          SCHED

Part Of Items
ULE    OF    ACCREDITATION    CERTIFICATE
Plastics collapsible containers for human blood and blood
components-Part 3:Blood bag systems with integrated features
GB 14232.3-2011
Blood Bag Part Of Items Plastics collapsible containers for human blood and blood
components-Part 3:Blood bag systems with integrated features
ISO 3826-3:2006
Blood
Transfusion
Apparatus 		Part Of Items Rubber transfusion tubes GB 4491-2003
Blood
Transfusion
Apparatus 		Part Of Items Transfusion sets for single use-Part 1:Gravity feed GB
8369.1-2019

Blood
Transfusion
Apparatus 		Part Of Items Transfusion sets for single use-Part 2:With pressure infusion
apparatus use GB8369.2-2020
Infusion
Apparatus 		Part Of Items Infusion sets for special purpose-Part 1:Infusion setfor single use
with micropore filters YY 0286.1-2019
Infusion
Apparatus 		Part Of Items SCHED Special infusion setsT-APart 2cBurette-type infusion sets for
single use--Gravity feed YY 0286.2-2006
Infusion
Apparatus 		Part Of Items Special infusion sets-Part 3:Light-resistant infusion sets for single
use YY 0286.3-2017
Infusion
Apparatus 		Part Of Items Infusion access adapters-Part 1:Needle access adapters(Heparin
plugs)YY/T 0581.1-2011
Infusion
Apparatus 		Part Of Items Infusion access adapter-Part 2:Needleless access adapters YY/T
0581.2-2011
Infusion
Apparatus 		Part Of Items    Fluid lines for use with pressure infusion equipent and
accessories for single use-Part1:Fluid lines YY 0585.1-2019
Infusion
Apparatus 		Part Of Items Fluid lines for use pressure infusion equipent and accessories for
single use-Part 2:Accessories YY0585.2-2019
Infusion
Apparatus 		Part Of Items Fluid lines for use pressure infusion equipment and accessories
for single use-Part 3:Filters YY0585.3-2018
Infusion
Apparatus 		PartOf ltems SCHED Fluidolinescfor use Twithopressure infusion equipment and
accessories for single use.Part 4:Check valves YY 0585.4-2009
Infusion
Apparatus 		PartOf Items Special infusion sets--Part 4:Infusion sets for single use with
pressure infusion apparatus YY/T0286.4-2020
Infusion
Apparatus 		Part Of Items Special infusion sets-Part 5:Bottle-type and bag-type infusion
sets for single use YY/T 0286.5-2021
Infusion
Apparatus 		Part Of Items Special infusion sets-Part 6:Infusion sets for single use with
graduated flow regulator YY/T 0286.6-2020
Hanging
Deviced For
Infusion
Bottles 		All Of Items Disposable hanging devices for transfusionand infusion bottles-
Requirements andtest methods ISO 15010:1998
Hanging
Deviced For
Infusion
Bottles 		All Of Items Medical infusion bottles--Suspension devices for multiple use --
Requirements and test methods ISO 15375:2010
Hanging
Deviced For 		All Of Items   Hanging deviced for infusion bottles --Part 1:Disposable
hanging devices YY/T 0582.1-2005
Infusion
Bottles
Hanging
Deviced For
Infusion
Bottles 		AAIIOfltemsLACCF Hanging deviced for infusion bottles --Part 2:Multiple hanging
devices YY/T 0582.2-2005
Silicone rubber
pipes and
elastic parts 		Part Of Items Silicone tubes and elastomeric parts for infusion and transfusion
YY/T 0031-2008
Blood pressure
transmission
line 		Part Of Items Particular requirements of the safety and essential performance
for blood pressuretransmission tubes for use with invasive blood
pressure monitoring equipment YY/T 0754-2009
Infusion Bag Part Of Items Parenteral nutrient containers for single use YY/T 0611-2020
Transfer sets
for
pharmaceutical
preparations 		Part Of Items Transfer sets for pharmaceutical preparations-Requirements and
test methods YY 0804-2010
Transfer sets
for
pharmaceutical
preparations 		Part Of Items Transfer sets for pharmaceutical preparations —Requirements
and test methods ISO 22413:2021
Injection
Syringe 		Part Of Items Sterile syringes for single use GB 15810-2019
Injection
Syringe 		Part Of Items Sterile hypodermic syringes for single use —Part 1:Syringes for
manual use ISO 7886-1:2017
Injection
Needle 		A   NATIONAL   ACCH
Part Of Items 		Sterile hypodermic needles for single use GB 15811-2016
Injection
Needle 		Part Of Items Sterile hypodermic needles for single use ISO 7864:2016
Injection
Needle 		Part Of Items Dentistry --Sterile injection needles for single use ISO
7885:2010
Injection
Needle 		All Of Items Syringe needle YY/T 0282-2009
Injection
Needle 		Part Of Items Sterile dental injection needles for single use YY/T 0587-2018
Acupuncture
Needles 		Part Of Items Acupuncture needles GB 2024-2016
Stainless steel
syringe 		All Of Items Stainless steel needle tubing for the manufacture of medical
devices GB/T 18457-2015
Stainless steel
syringe 		All Of Items Stainless steel needle tubing for the manufacture of medical
devices ISO 9626:2016

Miscellaneous
Instruments 		All Of Items Conical fittings with a 6%(Luer)taper for syringes,needles and
certain other medical equipment—Part 1:General requirement
GB/T 1962.1-2015
Luer Taper All Of Items Conical fittings with a 6%(Luer)taper for syringes,needles and
certain other medical equipment—Part 2:Lock fittings GB/T
1962.2-2001
Luer Taper All Of Items Small-bore connectors for liquids and gases in healthcare
applications-Part 1:General requirements YY/T0916.1-2021
Injection
Syringe 		All Of Items Sterile hypodermic syringes for single use Part 2:Syringes for
use with power-driven syringe pumps ISO7886-2:2020
Injection
Syringe 		Part Of Items Sterile hypodermic syringes for single use-Part2:Syringes for
use with power-driven syringe pumps YY/T 0573.2-2018
Syringe All Of Items Sterile hypodermic syrings for single use-Part 3:Auto-disable
svrings for fixed dose immunization ISO7886-3:2020
Syringe All Of Items Sterile hypodermic syrings for single use-Part 4:Syringes with
re-use prevention feature ISO 7886-4:2018
Syringe Part Of Items Sterile hypodermic syrings for single use-Part 4:Syringes with
re-use prevention feature YY/T0573.4-2020
Venous
Indwelling
Needle 		Part Of Items Intravenous catheter for single use YY 1282-2016
Plunger seal of
syringes 		Part Of Items Plunger seal of syringes for single use YY/T 0243-2016
Filters Part Of Items Single-use filter for syringe YY/T 0908-2013
Injection
Syringe 		Part Of Items Low resistance syringe for single use YY/T 0909-2013
Syringe Part Of Items Sterile insulin syringe for single use YY/T 0497-2018
entry needle A    NATIONAL    ACC
Part Of Items
            SCHED 		床Needle-based injection systems for medicalfusel干Requirements
and test methods—Part 2:Double-ended pen needles ISO
11608-2:2022
Containers and
integrated fluid
paths 		Part Of Items Needle-based injection systems for medical use —Requirements
and test methods—Part 3:Containers and integrated fluid paths
ISO 11608-3:2022
Syringe Part Of Items Dispensing syringe for single use YY/T 0821-2022

Portable
infusion
devices 		Part Of Items Portable infusion devices for single use-Non electrically driven
YY0451-2010
Venous
Indwelling
Needle 		Part Of Items Intravenous catheter for single use YY/T 1282-2022
Syringes With
All-Glass 		Good Sealing Test method of leakage between barrel and plunger of medical
glass syringes YY/T91017-1999
Syringes With
All-Glass 		All Of Items Syringes With All-Glass YY 1001-2024
Syrings All Of Items Sterile hypodermic syrings for single use-Part 3:Auto-disable
syrings for fixed dose immunization YY/T0573.3-2019
Breast biopsy
needle and
rotaryincision 		All Of Items Breast biopsy and excision equipment YY/T 1929-2024
needle
Injection
Syringe 		All Of Items Sterile single-use syringes,with or without needle,for insulin
ISO 8537:2016
Liquid
medicine
filtration
products 		Integrity Test For
Fluid Filters 		Sterilizing-grde filters for medical infusion equipments-Part1:
Integrity test for fluid filters YY/T0929.1-2014
heat stability Liquid filters for medical infusion equipments-Part 2:Test method
fordetermining candida albicans retention of 1.2 μm filter YY/T
0929.2-2018
Hypodermic
needles 		Color Scale      Hypodermic needles for single use-Colour coding for
identification ISO 6009:2016
     Hypodermic needles for single use-Colour coding for
identification YY/T 0296-2022
Injection
needle,
interventional
catheter guide
needle and
blood sample
collection
needle 		Sharp Object
Damage Protection 		Sharps injury protection-Requirements and test methods-Sharps
   protection features for single-use hypodermic needles,
introducers for catheters and needles used for blood sampling
ISO 23908:2011

Enteral feeding
catheters 		Part of Parameters Enteral feeding catheters and enteral giving sets for single use
and their connectors-Design and testing YY/T 0483-2004
Enteral feeding
catheters 		All Of Items Physical performance requirements and test methods for enteral
feeding catheters with a retention balloon YY/T0817-2010
Subcutaneous
infusion set 		Part Of Items Single use subcutaneous infusion sets for use with insulin pump
YY/T 1291-2016
Catheter 2019 

Dilating
Catheter
Part Of Items
               C
Intrauterine compression balloon for single use YY/T 1798-
床202ITATION

Drainage
Catheter 		          SCHED
Part Of Items
Sterile drainage catheters and accessory devices for single use
YY/T 0489-2004

Drainage
Catheter 		Part Of Items Intracranial external drainage system-Part 1:Collecting sets for
external drainage by intracranial puncture YY/T 1287.1-2016

Drainage
Catheter 		Part Of Items Intracranial external drainage system-Part 2:Collecting sets for
external drainage by lumberpuncture YY/T 1287.2-2016

Drainage
Catheter 		Part Of Items Intracranial external drainage system-Part 3:Intracranial external
drainage catheter YY/T 1287.3-2016
Ureteral Stents Part Of Items Test methods for ureteral stents YY/T 0872-2013
Drainage
Catheter 		Part Of Items Sterile drainage catheters and accessory devices for single use
YY/T 0489-2023
Catheter Part Of Items Sterile urethral catheter for single use YY/T0325-2022

Sterile
drainage
catheters and
accessory
devices 		Part Of Items
A       NATIONALA 		Sterile drainage catheters and accessory devices for single use
ISO 20697:2018
Urine
collection bags 		All Of Items Urine collection bags--Part 2:Requirements and test methods
GB/T 17257.2-2009
Urine
collection bags 		All Of Items Urine collection bags--Part 2:Requirements and test methods ISO
8669-2:1996
Chest Drainage
Systems 		All Of Items Chest drainage systems for single use-Part1:Type of water-seal
YY/T 0583.1-2015
Chest Drainage
Systems 		All Of Items Chest drainage systems for single use -Part 2:Type of dry seal
valve YY/T0583.2-2016
Suction
Equipment 		All Parameters Medical suction equipment -Part 3:suction equipment powered
from a vacuum or pressure source YY/T 0636.3-2021
Suction
Equipment 		All Parameters Medical suction equipment-Part 2:manually powered suction
equipment YY/T 0636.2-2021
Suction
Equipment 		All Parameters Medical suction qeuipment Part 1:Electrically powered suction
equipment YY/T 0636.1-2021
Draining
sponge 		Partial Parameters   Sponge for negative pressure wound therapy YY/T 1872-2022
Medical
Suction
Equipment 		All Parameters     Medical suction equipment —Part 3:Suction equipment
  powered from a vacuum or positive pressure gas source ISO
10079-3:2022
Medical
Suction 		All Parameters Medical suction equipment —Part 4:General requirements ISO
10079-4:2021
Equipment
Medical
Suction
Equipment 		All Parameters Medical suction qeuipment Part 2:Manually powered suction
equipment EN ISO-10079-2:2022
Medical
Suction
Equipment 		           SCHED
All Parameters 		Medical suction qeuipment Part IEElectricafly powered suction
equipment EN ISO 10079-1:2022
Medical
Suction
Equipment 		All Parameters Medical suction qeuipment Part 1:Electrically powered suction
equipment ISO 10079-1:2022
Medical
Suction
Equipment 		All Parameters Medical suction equipment —Part 4:General requirements EN
ISO 10079-4:2021
Medical
Suction
Equipment 		All Parameters Medical suction equipment —Part 3:Suction equipment
powered from a vacuum or positive pressure gas source EN ISO
10079-3:2022
Medical
Suction
Equipment 		All Parameters Medical suction qeuipment Part 2:Manually powered suction
equipment ISO 10079-2:2022
Gel Part Of Items Medical sodium hyaluronate gel YY/T 0308-2015
Sponge Part Of Items Absorbable gelatin sponge YY/T 1283-2016
sponge Part Of Items Collagen sponge YY/T 1511-2017
Sodium
hyaluronate
A     NATIONAL     ACC
Partial Parameters ED
REDITATIONSERVICE      FOR      CONFORMITY      ASSESSME
Tissue engineering medical device products-Sodium hyaluronate
YY/T1571-2017
Medical
carboxymethyl
chitosan 		Partial Parameters Medical carboxymethyl chitosan YY/T0953-2020
Recombinant
humanized
collagen
protein 		All Of Items Recombinant humanized collagen protein YY/T 1888-2023
Dressings All Of Items Non-active medicaldevices—-Performancerequirements and
testmethods for absorbentcotton gauze and absorbent cotton
andviscose gauze EN 14079:2003
Absorbent
cotton gauze 		All Of Items Performance requirements and test methods for absorbent cotton
gauze and Performance requirements and test methods for
absorbent cotton gauze andabsorbent cotton and viscose gauze
YY/T0331-2006
Dressings All Of Items General requirements for surgical gauze dressings YY 0594-2006
Medical
absorbent
cotton 		Part Of Items Medical absorbent cotton YY/T0330-2015
Cleanroom
garment 		Easy To Fall Off
Large Particles 		Cleanroom garment-Test method of easy shed large particles
FZ/T 80013-2012
Static
protective
clothing 		A   NATIONAL   ACCF
Part Of Items 		Protective clothing-Static protective clothing GB 12014-2019
Surgical gloves All Of Items Single-use sterile rubber surgical gloves GB/T 7543-2020
Surgical
Gloves 		All Of Items Single-use medical poly(vinyl chloride)examination gloves
GB 24786-2009
Surgical
Gloves 		All Of Items Single-use non-sterile rubber surgical gloves GB/T 24787-
2009
Surgical
Gloves 		All Of Items Single-use sterile rubber surgical gloves --Specification ISO
10282:2023

Surgical
Gloves 		All Of Items Single-use medical examination gloves —Part 1:Specification
for gloves made from rubber latex or rubber solution ISO 11193-
1:2020
Surgical
Gloves 		All Of Items Single-use medical examination gloves--Part 2:Specification for
gloves made from poly(vinyl chloride)ISO 11193-2:2006
Rubber gloves All Of Items Single-use rubber gloves forgeneral applications一Specification
ISO 25518:2021
Surgical Mask Part Of Items surgical masknasal splint3 YY0469-2011
Sterile Surgical
Films 		Part Of Items Sterile surgical films for single use YY 0852-2011
Surgical drapes
,gowns and
cleanair suits
A    NATIONAL    ACC
All Of ItemssCHED 		R
Surgical drapes,gowns and clean air suits for patients,clinical
staff and equipmentTPart2;Performance requirements and test
methods YY/T0506.2-2016
Medical glove Removable Surface
Powder And Water-
Extractable Protein 		Limit for the removable surface powder and water-extractable
protein of medical gloves GB24788-2009
Medical glove Limit For The
Removable Surface
Powde 		  Medical gloves-Determination of removable surface powder
GB/T 21869-2008
Medical glove Water-Extractable
Protein 		Medical gloves made from natural rubber latex-Determination of
water-extractable protein using the modified Lowry method
GB/T 21870-2008
Medical glove
Limit For Water-
Extractable Protein 		Medical gloves made from natural rubber latex-Determination of
water-extractable protein using the modified Lowry method ISO
12243:2003+A1:2012
Surgical  sheet,
surgical gown
and clean
clothes 		Floc Dropping Surgical drapes,gowns and clean air suits for patients,clinical
staff and equipment-Part 4:Test method for linting in the dry
state YY/T0506.4-2016
Surgical  sheet,
surgical gown
andclean
clothes 		Biogenic
Penetration-Dry
State 		Surgical drapes,gowns and clean air suits for patients,clinical
staff and equipment-Part 5:Test method for resistance to dry
microbial penetration YY/T0506.5-2009
Surgical  sheet,
surgical gown 		Prevent Microbial
Penetration -Wet 		Surigical drapes,gowns and clean air suits,used as medical
devices,for patients,clinical staff and equipment-Part 6:Test
Surgical drapes
,gowns and
clean air suits 		All Of Items Surgical drapes,gowns and clean air suits for medical usePart
1:General requirements YY/T 0506.1-2023
Surgical drapes
,gowns and
clean air suits 		Part Of Items Surgical drapes,gowns and clean air suits for patients,clinical
staff andequipment-Part-8:Special requirements for products
YY/T0506.8-2019
Surgical sheet,
surgical gown
and clean
clothes 		Resistance To Dry
Microbial
Penetration 		Clothing for protection against infectious agents --Test method
for resistance to dry microbial penetration ISO22612:2005
Surgical sheet,
surgical gown
and clean
clothes 		ResistanceTo Wet
Bacterial
Penetration 		  Surgical drapes,gowns and clean air suits,used as medical
devices,for patients,clinical staff and equipment --Test method
to determine the resistance to wet bacterial penetration ISO
22610:2018
Silk quilts Electrostatic
Properties 		Anti-static requirement and test methods of working clothing
GB/T 23316-2009
medical
mask 		Part Of Items Single-use medical face mask YY/T0969-2013
Disposable
medical rubber
inspection
gloves 		All Of Items   Disposable medical rubber inspection gloves GB 10213-2006
Protective
Mask 		Part Of Items 42 CFR Part 84 Respiratory Protective Devices 42 CFR Part 84
Protective
Mask
Part Of Items
A 		Respiratory protection-Non-powered air-purifying particle
respirator GB 2626-2019EI
Protective
clothing 		All Of Items SCHED Protective clothingDIGeneral requirements GB/T20097-2006
Protective
Mask 		All Of Items Technical specification for daily protective masks GB/T 32610-
2016
Children Mask Part of Parameters Technical specifications for masks for children GB/T 38880-2020
Protective
Mask 		Part Of Items Respiratory protective devices-Filtering half masksto protect
against particles-Requirements,testing,marking BS EN
149:2001+A1:2009
Protective
Shoe Covers 		All Of Items Single-use medical protective overboot YY/T 1633-2019
Crash Helmet All Of Items Single-use medical protective hood YY/T 1642-2019
Protective
mask 		All Of Items Medical face masks-Requirements and test methods BS EN
14683:2019+AC:2019
Protective
Mask 		Part Of Items Single-use medical face mask YY/T 0969-2013
Protective
Mask 		Part Of Items Protective face mask for medical use GB 19083-2023
Protective
clothing 		Part OfItems Disposable protective clothing for medical use GB 19082-2023
Protective
clothing 		All Of Items    Protective clothing --General requirements AMENDMENT 1
ISO 13688:2013+A1:2021
Protective
Mask 		All Of Items Standard specification for performance of materials used in
medical face masks ASTM F2100-23
Protection suit The Resistance To
Puncture 		Protective clothing-Mechanical properties-Determination of the
resistance to puncture ISO 13996:1999
Protective clothing-Mechanical properties-Determination of the
resistance to puncture GB/T 20655-2006
Protection suit Splash Resistance
Pressure 		clothing for protection against infectious agents--medical face
masks-testmethod for resisitance against penetration by synthetic
blood(fixedvolume,horizontally projected)ISO 22609:2004
Protective
clothing 		Resistance to blood
and body fluid
penetration 		Clothing for protection against contact with blood and body
fluidsDetermination of the resistance of protective clothing
materials topenetration by blood and body fluids-Test method
using synthetic blood YY/T 0700-2008
Clothing for protection against contact with blood and body
fluidsDetermination of the resistance of protective clothing
materials topenetration by blood and body fluids-Test method
using synthetic blood ISO 16603:2004
protection suit Comprehensive
ColourFastness 		Textiles--Tests for colour fastness--Comprehensive colour
fastness GB/T14575-2009
Protective
Equipment 		Penetration Of
Filer Material 		    Respiratory protective devices -Methods of test-Part
7:Determination of particle filter penetration EN 13274-7:2019

Protective
Equipment 		Resistance To
Penetration By
Synthetic Blood 		standard test method for resistance of medical face masks to
penetration by synthetic blood ASTMF1862/F1862M-17
Protective
Equipment 		Aqueous
Extractable Protein
Content 		Standard Test Method for Analysis of Aqueous Extractable
Protein in Latex,Natural Rubber,and Elastomeric Products
Using the Modified Lowry Method ASTM D5712-15(2020)
Protective
Equipment 		Dimensions Standard Practice for Rubber—Measurement of Dimensions
ASTM D3767-03(2020)
Protective
Equipment 		Resistance To
Flame 		Respiratory protective devices -Methods of test -Part 4:Flame
tests EN 13274-4:2020
Protective
Equipment 		Pb,Hg,Cr Electrical and electronic products -Determination of six
  regulated substances (lead,mercury,cadmium,hexavalent
chromium,polybrominated biphenyls,polybrominated diphenyl
ethers)GB/T26125-2011
Protective
Equipment 		Abrasion Resistance StandardTest Method for Abrasion Resistance of Textile Fabrics
(Martindale Abrasion Tester Method)ASTM D4966-22
Protective
Equipment 		Tensile Stress Rubber,vulcanized or thermoplastic—Determination of tensile
stress-strain properties ISO37:2017
Protective
Equipment 		Resistance To
Penetration By
Synthetic Blood 		Clothing for protection against infectious agents-Medical face
masks--Test method for resistance against penetration by
synthetic blood (fixed volume ,horizontally projected)YY/T
0691-2008
Protective
Equipment 		Flam Mability Standard for the flammability of clothing textiles 16 CFR 1610
Protective
Gloves 		All Of Items Hand protection—General test methods GB/T 12624-2020
Protective
Gloves 		All Of Items Protective gloves -General requirements and test methods EN
ISO 21420:20204.1
Protective
Gloves 		All Of Items Protective gloves -General requirements and testmethods ISO
21420:2020+A1:20224.1
Facial Mask Part of Parameters Facial mask QB/E 2872-2017
Pure moxa
stick 		All Of Items Pure moxa stick GB/T40975-2021
Moxa floss
used in
moxibustion 		All Of Items Moxa floss used in moxibustion GB/T40976-2021
Operating
Tables 		Partial Parameters Medical electrical equipment -Part 2-46:Particular requirements
for basic safety and essential performance of operating tables EN
IEC 60601-2-46:2019