现行

BS EN 868-2-2017

Packaging for terminally sterilized medical devices-Sterilization wrap. Requirements and test methods
最终灭菌医疗器械的包装

2017-02-28

现行

SN/T 3061-2011

进口医疗器械灭菌包装检验操作规程
Rules of the inspection of packaging for import terminally sterilized medical devices

2011-09-09

现行

SN/T 3062.4-2011

进口医疗器械灭菌包装 第4部分：材料和预成型无菌屏障系统要求
Packaging materials for terminally sterilized medical devices for import-Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging

2011-09-09

现行

ISO/TS 16775-2021

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

2021-11-05

现行

KS P ISO 11607-1

최종 멸균 처리한 의료기기의 포장 — 제1부: 재료, 무균 장벽 시스템 및포장 시스템에 대한 요구사항
用于终端灭菌医疗器械的包装 - 第1部分:材料 无菌屏障系统和包装系统的要求

2018-11-05

现行

KS P ISO 11607-1

최종 멸균 처리한 의료기기의 포장 — 제1부: 재료, 무균 장벽 시스템 및 포장 시스템에 대한 요구사항
最终灭菌医疗器械的包装.第1部分:材料、无菌屏障系统和包装系统的要求

2021-06-28

现行

GB/T 19633.1-2015

最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

2015-12-10

现行

ISO 11607-1-2019

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
用于终端灭菌医疗器械的包装 - 第1部分:材料 无菌屏障系统和包装系统的要求

2019-01-31

现行

AAMI/ISO 11607-1-2019

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:材料、无菌屏障系统和包装系统的要求

现行

UNE-EN 868-2-2009

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
最终灭菌医疗器械的包装第2部分:灭菌包装要求和试验方法

2009-12-02

现行

UNE-EN 556-1-2002

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for terminally sterilized medical devices.
医疗器械的消毒 医疗器械被指定为“无菌”的要求 第1部分:最终灭菌医疗器械的要求

2002-02-28

现行

GOST EN 556-1-2011

Стерилизация медицинских изделий. Требования к медицинским изделиям категории «стерильные». Часть 1. Требования к медицинским изделиям, подлежащим финишной стерилизации
医疗器械灭菌医疗器械要求被指定为“无菌” 第一部分终末消毒医疗器械的要求

2011-11-29

现行

BS EN 868-4-2017

Packaging for terminally sterilized medical devices-Paper bags. Requirements and test methods
最终灭菌医疗器械的包装

2017-02-28

现行

BS EN 868-6-2017

Packaging for terminally sterilized medical devices-Paper for low temperature sterilization processes. Requirements and test methods
最终灭菌医疗器械的包装

2017-02-28

现行

YY/T 0698.2-2022

最终灭菌医疗器械包装材料　第2部分：灭菌包裹材料　要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods

2022-10-17

现行

YY/T 0615.1-2007

标示"无菌"医疗器械的要求　第1部分:最终灭菌医疗器械的要求
Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices

2007-07-02

现行

BS 6256-2021

Packaging for terminally-sterilized medical devices. Method for determination of methylene blue particulate penetration
最终灭菌医疗器械的包装 亚甲基蓝颗粒渗透性的测定方法

2021-01-25

现行

DIN CEN ISO/TS 16775

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
最终灭菌医疗器械的包装ISO 11607-1和ISO 11607-2的应用指南（ISO/TS 16775-2021）；德国版CEN ISO/TS 16775:2021

2022-04-01

现行

BS EN 868-8-2018

Packaging for terminally sterilized medical devices-Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
最终灭菌医疗器械的包装 符合EN 285的蒸汽灭菌器用可重复使用的灭菌容器 要求和试验方法

2019-01-09

现行

YY/T 0698.8-2009

最终灭菌医疗器械包装材料　第8部分：蒸汽灭菌器用重复性使用灭菌容器　要求和试验方法
Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods

2009-06-16