(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...
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...
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者或患者造成伤害。 2.有效性:医疗器械应按照规定的设计和制造标准进行,确保其功能正常,满足预期的使用要求。 3.法规遵从性:医疗器械的制造和使用应符合相关法规和标准的要求,确保...
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...
ISO16142-1addressesthistypeofprobleminEssentialPrincipleB.1.2(seeAnnexF): Thesolutionsadoptedbythemanufacturerforthedesignandmanufactureofthemedicaldevice shouldconformtosafetyprinciples,takingintoaccountthegenerallyacknowledgedstateofthe art.Whenriskreductionisrequiredthemanufacturershouldcontroltheriskssothattheresidual...
--第2部分:ANSI/AAMI/ISO11135-1应用指南 由医疗器械促进协会于2008年9月23日批准 由美国国家标准学会公司于2008年11月9日注册 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 ...
—医疗器械制造商根据ISO16142-1:2016[3]提供的信息的安全性和性能的基本原则,如附录C所示;和 —thegeneralsafetyandperformancerequirementsofamedicaldeviceaccordingtoregulation(EU) 2017/745[7]. —根据法规(EU)2017/745[7],医疗器械的一般安全和性能要求。 Inthisdocument,thefollowingverbalformsareused: 在本文件...
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