(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...
BSI Standards PublicationBS ISO 16142-1:2016Medical devices — Recognizedessential principles of safetyand performance of medicaldevicesPart 1: General essential principles andadditional specific essential principles for allnon-IVD medical devices and guidance onthe selection of standards...
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...
ISO 16142:2016 包括安全和性能的基本原则,确定了可用于评估医疗器械是否符合公认的基本原则的重要标准和指南,如果满足这些基本原则,则表明医疗器械是安全的并具有良好的性能如预期。 ISO 16142 的这一部分确定并描述了适用于所有医疗器械(包括 IVD 医疗器械(体外诊断))的安全和性能的六项一般基本原则。 ISO 16142:20...
ISO 16142-1:2016 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 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essentia...
标准号:ISO 16142-1:2016 EN 标准名称:医疗器械 医疗器械安全和性能的公认基本原则 第1部分:适用于所有非 IVD 医疗器械的一般基本原则和附加特定基本原则以及标准选择指南 英文名称:Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential princ...
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 国际标准分类(ICS): 11.040.01 发布...
—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[...
16142-21301中的体外诊断医疗设备。安全性值得关注的医疗设备的另一个来源是AAMITIR57口。 A.2问题 A.2.1预期用途是什么,医疗设备如何使用? 应考虑的因素包括: 医疗器械相对于: -诊断、预防、监测、治疗或减轻疾病, 一—对伤害的诊断、监测、治疗或减轻或赔偿, 一—解剖学或生理过程的调查、替换、修改或支持,或...