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(高清正版) ISO 16142-1-2016 下载积分: 3000 内容提示: © I S O 2 0 1 6M e d i c a l d e vi c e s — Re c o g n i z e d e s s e n ti a l p r i n c i p l e s o f s a fe ty a n d p e r fo r m a n c e o f m e d i c a l d...
ISO 16142-1-2016 下载积分: 2000 内容提示: © ISO 2016Medical devices — Recognized essential principles of safety and performance of medical devices —Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of...
ISO 16142-1-2016 © ISO 2016Medical devices — Recognized essential principles of safety and performance of medical devices —Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standardsDispositifs médicaux...
ISO16142-1:2016EN标准是关于医疗设备安全性和性能的公认基本原则的规范,其组成部分包括所有非IVD医疗设备的一般基本原则和所有非IVD医疗设备的额外特定基本原则以及标准的选取指南。 ISO16142-1:2016EN标准的主要内容包括以下几个方面: 一、一般基本原则 1.安全性:医疗器械的设计和制造应确保其在使用过程中不会对操作...
中文名称:医疗器械. 医疗器械安全性和性能的公认基本原则. 第1部分: 所有非IVD医疗器械的通用基本原则和额外具体基本原则和标准选择指南 英文名称:Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential...
ISO/TR 16142-2006 中文名称:医疗器械 医疗器械安全和性能公认基本原则的保障标准选用指南 英文名称:Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 中国标准分类(CCS):C30...
—theessentialprinciplesofsafetyandperformanceofamedicaldeviceaccordingtoISO16142-1:2016 asindicatedinAnnexC;and —符合ISO16142-1:2016的医疗器械安全性和性能的基本原则,如附录C所示;和 —thegeneralsafetyandperformancerequirementsofamedicaldeviceaccordingtoregulation(EU) 2017/745[18]. —根据法规(EU)2017/745[...
ISO16142-1:2016,Medicaldevices-Recognizedessentialprinciplesofsafetyandperformanceofmedical devices—Part1:Generalessentialprinciplesandadditionalspecificessentialprinciplesforallnon-IVD medicaldevicesandguidanceontheselectionofstandards ISO17664:2017,Processingofhealthcareproducts—Informationtobeprovidedbythemedicaldevice ...
摘要:AAMI/ISOTIR11135-2为医疗器械环氧乙烷灭菌过程的确认与常规控制提供指南。 关键词:EO,行业灭菌,确认,常规控制,医疗器械,产品放行,过程控制,过程挑战 分享高质量文档 分享高质量文档 发布方 医疗器械促进协会 1110N.GlebeRoad,Suite220 Arlington,VA22201-4795 ...