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EN 60601-2-52 Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds (IEC 60601-1-1& IEC 60601-1-2)
EN 60601-2-52
医疗电气设备第2-52部分:病床基本安全和基本性能的特殊要求

Clause

Test Category

201.9.1.101

Protection against patient entrapment in non-moving parts防止病人夹在非活动部位

201.9.2.2

Trapping zone区域防守

201.9.2.2.2

Gaps缺口

201.9.2.2.3

Safe distances安全距离

201.9.2.2.5

Continuous activation不断激活

201.9.2.3.1

Unintended movement无心的运动

201.9.4.2

Instability-overbalances不稳定-过度平衡

201.9.4.2.2

Instability excluding transport不稳定不包括运输

201.9.4.2.3

Instabiity from horizontal and vertical forces来自水平和垂直力量的不稳定性

201.9.4.2.4.2

Force for propulsion推进力量

201.9.4.2.4.3

Movement over a threshold阈值移动

201.9.4.3.1

Instability in transport运输的不稳定

201.9.4.3.2

Instability excluding transport不稳定不包括运输

201.9.4.4

Grips and other handling devices手柄和其他处理装置

201.9.6.2.1

Audible acoustic energy可听声能

201.9.8

Hazards associated with support systems与支持系统相关的危险

201.9.8.1

General一般

201.9.8.2

Tensile safety factory拉伸安全工厂

201.9.8.3

Strength of patient of operator support or suspension systems操作人员支撑或悬挂系统的病人强度

201.9.8.3.2

Static forces due to loading from persons由于人的负荷而产生的静力

201.9.8.3.3

Dynamic forces due to loading from persons由于人员负载而产生的动态力

201.9.8.3.3.1

General一般

201.9.8.3.3.2

Dynamic testing of the height adjustment mechanism高度调整机构的动态测试

201.9.8.3.3.3

Side rail strength and latch reliability侧轨强度和锁扣可靠性

201.9.8.3.3.4

Dynamic testing of the lifting pole起重杆的动态试验

201.9.8.4

Systems with mechanical protective devices带有机械保护装置的系统

201.9.8.4.1

General一般

201.9.8.5

Systems without mechanical protective devices没有机械保护装置的系统

201.9.101

Protection against inadvertent patient 防止疏忽的病人

201.10

Protection against unwanted and excessive radiation Hazards防止不必要的和过量的辐射危害

201.11

Protection against  excessive temperature and other hazards防止过热和其他危险

201.11.1

Maximum temperature during normal use正常使用时的最高温度

201.11.6.5

Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS水或颗粒物质进入设备和系统

201.11.6.6

Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS清洁和消毒ME设备和ME系统

201.11.6.6.101

Machine washable MEDICAL BED可机洗医疗床

201.11.8

Interruption of the power supply/SUPPLY MAINS TO ME EQUIPMENT电源供应/供电干线到ME设备的中断

201.12

Accuracy of controls and  instruments and protection against harzardous outputs控制和仪器的准确性和防止有害输出的保护

201.13

HAZARDOUS SITUATIONS and fault conditions危险情况和故障情况

201.14

PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS可编程电气医疗系统

201.15

Construction of  ME EQUIPMENT ME设备构造

201.15.3.4.1

HAND-HELD ME EQUIPMENTME手持设备

201.15.3.5

Rough handling test野蛮装卸测试

201.15.4

ME EQUIPMENT components and general assembly设备部件及总装

201.15.4.4

Indicators指标

201.15.4.6.2

Limitation of movement限制的运动

201.15.4.7.1

Mechanical strength机械强度

201.15.4.7.3

Entry of liquids液体的入口

201.15.4.101

HEAD/FOOT BOARD assembly/脚踏板总成

201.15.4.102

Mattress retention床垫保留

201.16

ME SYSTEMS ME系统

201.17

Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ME设备和ME系统的电磁兼容性

BB.2.2

The effect of impacts to the MATTRESS SUPPORT PLATFORM冲击对床垫支撑平台的影响

BB.2.3

 the effect of loading on the edge of the mattress support platform负载对床垫支撑平台边缘的影响

BB.2.4

Durability of the moveable sections (if provided) of the MATTRESS SUPPORT PLATFORM气垫支撑平台的可移动部分(如有)的耐久性

BB.3.2

Range of adjustment of the height of the MATTRESS SUPPORT PLATFORM床垫支撑平台的高度调节范围

BB.3.3

Dimensions for handles and pedals手柄和踏板的尺寸

BB.3.4

Operating forces for handles and pedals手柄和踏板的操作力

BB.4.2

Combination of MEDICAL BED and MOBILE hoists医疗床和移动式升降机的组合

BB.4.3

Combination of MEDICAL BED and mattress医疗床和床垫的结合

BB.4.4

Range of adjustment of moveable sections of the MATTRESS SUPPORT PLATFORM气垫支撑平台可移动部分的调整范围

Sample Size: 4 samples for manual beds and 4 set of electric elements for electric beds;Turnaround Time: 30 working days
样本量:手动床4件,电动床4套,周转时间30个工作日

Remarkneed the client  to provide the mattress
备注:需客户提供床垫


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