标准类别
Category

标准号
Standard No.

标准名称
Standard title

质量管理体系
Quality management system

ISO 13485-2016

Medical devices — Quality management systems —Requirements for regulatory purposes

医疗器械质量管理体系用于法规的要求

Medical devices-Quality Management Systems –Requirements for Regulatory Purposes

21 CFR 820 质量体系法规

ISO 14971:2012

Medical devices -- Application of risk management to medical devices

医疗器械质量管理体系医疗器械的风险管理应用

最终灭菌医疗器械的包装
Packaging for terminally sterilized medical devices

ISO 11607.1-2006

Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems

最终灭菌医疗器械的包装第1部分：原料、无菌屏障系统和包装系统的要求

ISO 11607.2-2006

Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes

最终灭菌医疗器械的包装第2部分：成型、密封和组装过程的确认要求

ISO /TS 16775-2014

Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2

最终灭菌医疗器械的包装- ISO 11607-1 和ISO 11607-2 的应用指南

环氧乙烷灭菌
Ethylene oxide sterilization

ISO 11135-2014

Sterilization of health care products --- Ethylene oxide --- Requirements for development, validation and routine control of a sterilization process for medical devices

医疗保健产品灭菌环氧乙烷医疗器械灭菌过程开发确认和常规控制

Sterilization of health care products –Ethylene oxide-Part 1:Requirements for development , validation and routine control of a sterilization process for medical devices

Sterilization of health care products –Ethylene oxide- Part 2:Guidence on the application of GB 18279.1

生物指示物
Biological indicator

ISO 11138.1-2017

11138-1 Sterilization of health care product — Biological indicators — Part 1: General requirements, 2nd edition

医疗保健产品灭菌生物指示物第1部分：通则

ISO 11138.2-2017

11138-2 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes, 3rd edition

医疗保健产品灭菌生物指示物第2部分：环氧乙烷灭菌过程用生物指示物

ISO14161-2009

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

医疗保健产品灭菌生物指示物选择、使用及检验结果判断指南

化学指示物
Chemistry indicator

ISO 11140.1-2014

Sterilization of health care products -- Chemical indicators -- Part 1: General requirements

医疗保健产品的灭菌化学指示剂第1部分：总要求

洁净室及相关受控环境
Cleanrooms and Associated Controlled Environments

ISO 14644.1-2015

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration

洁净室及相关受控环境第1部分：用粒子浓度确定空气洁净度等级

ISO 14644.2-2015

Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

洁净室及相关受控环境第2部分：用粒子浓度监测提供与空气洁净度相关的洁净室性能的证据

ISO 14644.3-2005

Cleanrooms and associated controlled environments - Part 3: Cleanrooms and associated controlled environments - Part 3: Test methods

洁净室和相关控制环境第3部分：试验方法

ISO 14644.4-2001

Cleanrooms and associated controlled environments -- Part 4: Design, construction and start-up

洁净室及相关受控束环境第4节:设计、施工和启动

ISO 14644.5-2004

Cleanrooms and associated controlled environments - Part 5: Operations

洁净室和相关控制环境第5部分：操作