Standard

Test content

ChP Part IV 0401

UV-VIS Spectrophotometry

ChP Part IV 0402

Infrared spectrophotometry

ChP Part IV 0406

Atomic absorption spectrophotometry

ChP Part IV 0412

Inductively coupled plasma mass spectrometry

ChP Part IV 0521

Gas chromatography

ChP Part IV 0631

Determination of pH value

ChP Part IV 0681

Determination of conductivity of pharmaceutical water

ChP Part IV 0682

Determination of total organic carbon in pharmaceutical water

ChP Part IV 0801

Chloride test

ChP Part IV 0808

Ammonium salt test

ChP Part IV 0821

Heavy metal test

ChP Part IV 0841

Inspection of burning residue

ChP Part IV 0901

Solution color test

ChP Part IV 0902

Clarity test

EN 455-1

Medical gloves for single use Part 1: Requirements and testing for freedom from holes

EN 455-2

Medical gloves for single use Part 2: Requirements and testing for physical properties

EN 455-4

Medical gloves for single use Part 4: Requirements and testing for shelf life determination

EN 1618

Catheters other than intravascular catheters — Test methods for common properties

EN 13726-1

Test methods for primary wound dressings —Part 1: Aspects of absorrbency

EN 13726-2

Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings

EN 13726-3

Non-active medical devices — Test methods for primary wound dressings — Part 3: Waterproofness

EN 13726-4

Non-active medical devices — Test methods for primary wound dressings — Part 4: Conformability

EN 13868

Catheters - Test methods for kinking of single lumen catheters and medical tubing

EN ISO 20695

Enteral feeding systems - Design and testing, Section 5 (Additional requirements for enteral giving sets and enteral extension sets), Section 6 (Additional requirements for enteral syringes), Section 7 (Additional requirements for enteral feeding catheters) (exclude Section 7.8 (Detectability))

EN ISO 20696

Sterile urethral catheters for single use, Section 6 (Specific requirements)

EN ISO 20697

Sterile drainage catheters and accessory devices for single use, Section 6 (Specific requirements)

EN ISO 20698

Catheter systems for neuraxial application - Sterile and single-use catheters and accessories, Section 7.2 (Pre-clinical evaluation) (exclude Section 7.2.2 (Radiopacity), Section 7.2.3 (Magnetic resonance compatibility))

GB/T 16886.7

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

GB/T 16886.12

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

GB/T 16886.17

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

GB/T 16886.18

Biological evaluation of medical devices — Part 18: Chemical characterization of materials

ISO 5361

Anaesthetic and respiratory equipment -Tracheal tubes and connectors, Section

5.5 (Cuff)

ISO 5366

Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors, Section 6.3 (Design) (exclude Section 6.3.10(Radiopaque marker))

ISO 5367

Anaesthetic and respiratory equipment - Breathing sets and connectors, Section 5 (Specific requirements), (exclude Section 5.1 (Materials))

ISO 7864

Sterile hypodermic needles for single use - Requirements and test methods, Section 4.3 (Cleanliness), Section 4.4 (Limits for acidity or alkalinity), Section

4.7 (Colour coding), Section 4.8 (Needle hub), Section 4.11 (Needle point), Section 4.12 (Bond between hub and needle tube), Section 4.13 (Latency of lumen)

ISO 7886-1

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

Section 6.2 (Limits for acidity or alkalinity), Section 8 (Tolerance on graduated capacity), Section 9 (Graduated scale), Section 10 (Barrel), Section 11 (Plunger stopper/Plunger assembly), Section 12 (Nozzle), Section 13(Performance)，

Section 13.1 (Dead space), Section 13.2 (Freedom from air and liquid leakage past plunger stopper), Section 13.3 (Force to operate the piston)

ISO 7886-2

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power- driven syringe pumps, Section 6 (Limits for acidity or alkalinity), Section 9 (Tolerance on graduated capacity), Section 14.1 (Dead space), Section 14.2 (Freedom from air and liquid leakage past the plunger stopper), Section 14.3 (Short-term flow rate error), Section 14.5 (Syringe Compliance)

ISO 7886-3

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization, Section 5 (Cleanliness), Section 6 (Limits for acidity or alkalinity), Section 9 (Tolerance on nominal capacity), Section 11.1 (Dimensions), Section 14.1 (Dead space), Section 14.2 (Freedom from air and liquid leakage), Section 14.3 (Auto-disable feature)

ISO 7886-4

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature, Section 5.2 (Limits for acidity or alkalinity), Section 7 (Tolerance on graduated capacity), Section 9.2 (Barrel flanges), Section 12.1 (Dead space), Section 12.2 (Freedom from air and liquid leakage), Section 12.3 (Re-use prevention feature)

ISO 8536-4

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed, Section 7.2 (Leakage), Section 7.3 (Test for tensile strength)

ISO 8536-8

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus, Section 6.2 (Test for tensile strength), Section 6.3 (Leakage), Section 6.14 (Storage volume)

ISO 8536-12

Infusion equipment for medical use - Part 12: Check valves for single use, Section 6.2 (Test for tensile strength), Section 6.3 (Leakage)

ISO 8536-13

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact, Section 6.3 (Test for tensile strength), Section 6.4 (Leakage)

ISO 8836

Suction catheters for use in the respiratory tract, Section 8 (Performance requirements) (excluding Section 8.6 (Radiopacity))

ISO 9377-2

Water quality — Determination of hydrocarbon oil index — Part 2: Method using solvent extraction and gas chromatography

ISO 9626

Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods, Section 5.2 (Surface Finish and Visual Appearance), Section 5.3 (Cleanliness), Section 5.4 (Limits for Acidity and Alkalinity), Section 5.8 (Stiffness), Section 5.9 (Resistance to Breakage), Section 5.10 (Resistance to corrosion)

ISO 10993-7

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

ISO 10933-12

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 10993-17

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

ISO 10993-18

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

ISO 11712

Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors, Section 5 (Requirements) (exclude Section 5.1.2 (Materials))

ISO 18562-2

Biocompatibility evaluation of breathing gas pathways in healthcare applications

— Part 2: Tests for emissions of particulate matter

ISO 18562-3

Biocompatibility evaluation of breathing gas pathways in healthcare applications

— Part 3: Tests for emissions of volatile organic compounds (VOCs)

ISO 18562-4

Biocompatibility evaluation of breathing gas pathways in healthcare applications

— Part 4: Tests for leachables in condensate Exclusions:

ISO 19227

Implants for surgery — Cleanliness of orthopedic implants — General requirements

ISO 20695

Enteral feeding systems - Design and testing, Section 5 (Additional requirements for enteral giving sets and enteral extension sets), Section 6 (Additional requirements for enteral syringes), Section 7 (Additional requirements for enteral feeding catheters) (exclude Section 7.8 (Detectability))

ISO 20696

Sterile urethral catheters for single use, Section 6 (Specific requirements)

ISO 20697

Sterile drainage catheters and accessory devices for single use, Section 6 (Specific requirements)

ISO 20698

Catheter systems for neuraxial application - Sterile and single-use catheters and accessories, Section 7.2 (Pre-clinical evaluation) (exclude Section 7.2.2 (Radiopacity), Section 7.2.3 (Magnetic resonance compatibility))

USP 643

Total Organic Carbon

USP 665

Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products

USP 1665

Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products