EN ISO 13485 标准查询与下载

DIN EN ISO 13485 2016 08 DIN EN ISO 13485 2016 08

DIN EN ISO 13485 Berichtigung 1:2017 医疗器械. 质量管理体系. 管制目的要求(ISO 13485-2016); 德文版本EN ISO 13485-2016, DIN EN ISO 13485-2016-08勘误表; 德文版本EN ISO 13485-2016/AC-2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016

DIN EN ISO 13485:2016 医疗器械.质量管理体系.调整要求(ISO 13485-2016).德文版本EN ISO 13485-2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016

DIN EN ISO 13485:2021 医疗器械 质量管理体系 监管要求（ISO 13485:2016）；德文版 EN ISO 13485:2016 + AC:2018 + A11:2021

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021

DIN EN ISO 13485:2012 医疗器械.质量管理体系.调整要求(ISO 13485-2003 + Cor. 1-2009).德文版本EN ISO 13485-2012 + AC-2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012

DIN EN ISO 13485:2010 医疗装置.质量管理体系.调整要求(ISO 13485-2003 + Cor. 1-2009).德文版本EN ISO 13485-2003 + AC-2009

This standard specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009

DIN EN ISO 13485/A1 E:2019 文件草案 医疗器械 质量管理体系 监管要求（ISO 13485:2016） 德文版和英文版 EN ISO 13485:2016/prA1:2019

Draft Document - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019

NS-EN ISO 13485:2000 质量体系 医疗器械 EN ISO 9001 应用的特殊要求（ISO 13485:1996）

  Full Description This International Standard specifies, in conjunction with ISO 9001, the quality System requirements

Quality systems — Medical devices — Particular requirements for the application of EN ISO 9001 (ISO 13485:1996)

UNE-EN ISO 13485:2001 质量体系 医疗器械 EN ISO 9001 应用的特殊要求 （ISO 13485:1996）

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. (ISO 13485:1996)

EN ISO 13485:2016 医疗器械.质量管理体系.用于监管目的的要求（ISO 13485:2016）

Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation gefordert ist, ihre Fähigkeit zur

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

DS/EN ISO 13485:2021 医疗器械“质量管理体系”监管要求（ISO 13485:2016）

Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

LST EN ISO 13485:2012 医疗器械 质量管理体系 监管要求（ISO 13485:2003+Cor.1:2009）

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003+Cor.1:2009)

EN ISO 13485:2003 医疗器械.质量管理体系用于法规的要求.合并勘误表2007年6月［代替:CEN EN 46003,CEN EN ISO 13488］

Medical devices - Quality management systems - Requirements for regulatory purposes Incorporating corrigendum June 2007 [Superseded: CEN EN 46003, CEN EN ISO 13488]

NS-EN ISO 13485:2016 医疗器械 质量管理体系 监管要求（ISO 13485:2016）

  Full Description ADOPTED_FROM:EN ISO 13485:2016 ISO 13485:2016 specifies requirements for a quality management system where

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

NS-EN ISO 13485:2012 医疗器械 质量管理体系 监管要求（ISO 13485:2003）

  Full Description ADOPTED_FROM:EN ISO 13485:2012 ISO 13485:2003 specifies requirements for a quality management system where

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)