发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22
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本标准鉴别习惯上使用的符号,这些符号对维护使用者使用者与其它人之安全与有效使用医疗器材分享。本标准主要预定使用于:? 于许多国家市场销售产品需使用不同语言医疗器材标示的医疗器材制造商;? 购自许多来源及具备多种的语言能力以提供医疗器材的使用者;? 负责上市后监
Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied
本标准规范制造商为识别医疗器材及其附件包括体外诊断用的医疗器材在内危害性之程序、估计及评估风险、控制这些风险和监视控制的有效性。本标准可应用于医疗器材生命周期中之所有阶段,但不适用于使用医疗器材时之临床判断。本标准并不规范可接受的风险等级,亦不要求制造商
Medical devices - Application of risk management to medical devices
Medical devices. Electrically generated alarm signals.
Use of medical devices - Risk management relative to the use of medical devices in health care establishments.
Information supplied by the manufacturer of medical devices.
Information supplied by the manufacturer with medical devices.
本标准提供临床上使用之聚合物医疗器材其降解产物定性及定量试验之设计时所须遵循之一般规定指引。并规范两种产生降解产物之方式:其一为作为筛选方式之加速降解试验,另一种则为实时降解试验。对于原位聚合之材料则取固化或硬化后之聚合物进行试验。所产生之数据则使用于聚
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Stainless steel needle tubing for the manufacture of medical devices.
Dentistry. Medical devices for dentistry. Dental implants
1 Przedmiotem normy s? wspólne wymagania i badania dotycz?ce elementów do ??czenia ko?ci, stosowane w chirurgii kostnej. 2. Normy zwi?zane PN-71
Medicall instruments Bon? joining elements Re?uirements and tests
Performance evaluation of in vitro diagnostic medical devices
Graphical symbols for use in the labelling of medical devices.
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices.
本标准鉴别习惯上使用的符号,这些符号对维护使用者使用者与其它人之安全与有效使用医疗器材分享。本标准主要预定使用于:? 于许多国家市场销售产品需使用不同语言医疗器材标示的医疗器材制造商;? 购自许多来源及具备多种的语言能力以提供医疗器材的使用者;? 负责上市后监
Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied
本标准规范制造商为识别医疗器材及其附件包括体外诊断用的医疗器材在内危害性之程序、估计及评估风险、控制这些风险和监视控制的有效性。本标准可应用于医疗器材生命周期中之所有阶段,但不适用于使用医疗器材时之临床判断。本标准并不规范可接受的风险等级,亦不要求制造商
Medical devices - Application of risk management to medical devices
Medical devices. Electrically generated alarm signals.
Use of medical devices - Risk management relative to the use of medical devices in health care establishments.
Information supplied by the manufacturer of medical devices.
Information supplied by the manufacturer with medical devices.
本标准提供临床上使用之聚合物医疗器材其降解产物定性及定量试验之设计时所须遵循之一般规定指引。并规范两种产生降解产物之方式:其一为作为筛选方式之加速降解试验,另一种则为实时降解试验。对于原位聚合之材料则取固化或硬化后之聚合物进行试验。所产生之数据则使用于聚
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Stainless steel needle tubing for the manufacture of medical devices.
Dentistry. Medical devices for dentistry. Dental implants
1 Przedmiotem normy s? wspólne wymagania i badania dotycz?ce elementów do ??czenia ko?ci, stosowane w chirurgii kostnej. 2. Normy zwi?zane PN-71
Medicall instruments Bon? joining elements Re?uirements and tests
Performance evaluation of in vitro diagnostic medical devices
Graphical symbols for use in the labelling of medical devices.
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices.