GOST R 56431-2015
Система менеджмента качества. Изделия медицинские. Руководство по валидации процессов
质量管理体系 医疗设备 过程验证指导
BS PD IEC/TR 80001-2-5-2014
Application of risk management for IT-networks incorporating medical devices-Application guidance. Guidance on distributed alarm systems
风险管理在医疗设备IT网络中的应用
2014-12-16
UNE-CEN ISO/TR 14969-2006 IN
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
医疗器械质量管理体系ISO 13485-2003应用指南
2006-02-15
GOST R ISO/TR 14969-2007
Изделия медицинские. Системы менеджмента качества. Руководство по применению ISO 13485:2003
医疗设备 质量管理体系 关于ISO 13485:2003应用指南
BS PD ISO/TR 80001-2-6-2014
Application of risk management for IT-networks incorporating medical device-Application guidance. Guidance for responsibility agreements
风险管理在医疗设备IT网络中的应用
2014-11-30
AAMI/IEC TIR80001-2-5-2014
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
包含医疗设备的IT网络的风险管理应用第2-5部分:应用指南分布式报警系统指南
2014-12-24
IEC TR 80001-2-5-2014
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
包含医疗设备的IT网络的风险管理应用第2-5部分:应用指南分布式报警系统指南
2014-12-16
IEC/TR 80001-2-5-2014
Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
包含医疗器械的IT网络的风险管理应用 - 第2-5部分:应用指南 - 分布式报警系统的指导
2014-12-17
GOST R 56432-2015
Система менеджмента качества. Изделия медицинские. Руководство по управлению продукцией и услугами, получаемыми от поставщиков
质量管理体系 医疗设备 从供应商获得的产品和服务的控制指导
GOST R 56430-2015
Система менеджмента качества. Изделия медицинские. Руководство по корректирующим и предупреждающим действиям и связанным процессам системы менеджмента качества
质量管理体系 医疗设备 关于纠正措施和预防措施及相关质量管理体系流程的指导意见
BS EN 9137-2012
Quality management systems. Guidance for the Application of AQAP 2110 within an EN 9100 Quality Management System
质量管理体系 EN 9100质量管理体系中AQAP 2110的应用指南
2012-02-29
ASD-STAN prEN 9137
Quality management systems - Guidance for the Application of AQAP 2110 within an EN 9100 Quality Management System
质量管理体系.EN 9100质量管理体系中AQAP 2110的应用指南
2010-03-31
BS PD IEC/TR 80001-2-3-2012
Application of risk management for IT-networks incorporating medical devices-Guidance for wireless networks
风险管理在医疗设备IT网络中的应用
2012-07-10
BS PD ISO/TR 4450-2020
Quality management systems. Guidance for the application of ISO 19443:2018
质量管理体系 ISO 19443:2018应用指南
2020-09-29
ISO/TR 4450-2020
Quality management systems — Guidance for the application of ISO 19443:2018
质量管理体系ISO 19443:2018应用指南
2020-09-18
BS PD IEC/TR 80001-2-4-2012
Application of risk management for IT-networks incorporating medical devices-Application guidance. General implementation guidance for healthcare delivery organizations
风险管理在医疗设备IT网络中的应用
2012-11-29
AAMI/ISO 13485-2016/(R)2019
Medical devices - Quality management systems - Requirements for regulatory purposes
医疗器械.质量管理体系.监管要求
2016-03-25
BS BIP 0115-2014
Implementing an ISO 13485 Quality Management System for Medical Devices
实施ISO 13485医疗器械质量管理体系
2014-04-04
KS P ISO 13485
의료기기 — 품질경영시스템 — 규제 목적을 위한 요구사항
医疗器械 - 质量管理体系 - 管理要求
2018-11-05
BS EN ISO 13485-2016+A11-2021
Medical devices. Quality management systems. Requirements for regulatory purposes
医疗设备 质量管理体系 监管要求
2021-09-08