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

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

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

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

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

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

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

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

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

ISO 11607-1-2019/Amd 1-2023

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
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修改件1:风险管理的应用

2023-09-13

现行

DIN EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; English version of DIN EN 556-1
医疗器械的灭菌.指定为“无菌”的医疗器械的要求.第1部分:最终灭菌医疗器械的要求；德文版EN 556-1:2001

2002-03-01

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

BS PD CEN 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应用指南

2021-11-26

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

UNE-EN 868-4-2009

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
最终灭菌医疗器械的包装第4部分:纸袋要求和试验方法

2009-12-02

现行

UNE-EN 868-6-2009

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
最终灭菌医疗器械的包装第6部分:低温灭菌用纸要求和试验方法

2009-12-02

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

现行

KS P ISO 11607-2

최종 멸균 처리한 의료기기의 포장 —제2부: 성형, 봉함 및 조립 공정에 대한 유효성 확인 요구사항
最终灭菌医疗器械的包装.第2部分:成型、密封和装配工艺的验证要求

2021-06-28

现行

KS P ISO 11607-2

최종 멸균 처리한 의료기기의 포장 — 제2부: 성형, 봉함 및 조립 공정에 대한 유효성 확인 요구사항
终端灭菌医疗器械的包装 - 第2部分:成型 密封和装配过程的验证要求

2018-11-05