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

现行

ISO 11607-2-2019

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
最终灭菌医疗器械包装第2部分:成形 密封和装配过程的验证要求

2019-01-31

现行

AAMI/ISO 11607-2-2019

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、密封和组装工艺的验证要求

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 ISO 11607-2-2007

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
最终灭菌医疗器械的包装第2部分:成型、密封和组装工艺的验证要求

2007-03-28

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

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 11607-2-2019/Amd 1-2023

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
最终灭菌医疗器械包装第2部分:成型、密封和组装过程的验证要求修改件1:风险管理的应用

2023-09-13

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

GOST ISO 11737-2-2011

Стерилизация медицинских изделий. Микробиологические методы. Часть 2. Испытания на стерильность, проводимые при валидации процессов стерилизации
医疗器械灭菌微生物方法 第2部分:验证灭菌过程中进行的无菌试验

2011-11-29

现行

SN/T 3062.2-2011

进口医疗器械灭菌包装 第2部分：纸袋-要求和试验方法
Packaging materials for terminally sterilized medical devices for import-Part 2:Paper bags-Requirements and test methods

2011-09-09

现行

GB/T 19973.2-2018

医疗器械的灭菌　微生物学方法　第2部分：用于灭菌过程的定义、确认和维护的无菌试验
Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process

2018-03-15

现行

KS P ISO 11737-2

의료기기의 멸균 — 미생물학적 방법 — 제2부: 멸균 공정의 정의, 유효성 확인 및유지에서 수행되는 멸균확인 시험
医疗器械的灭菌 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中执行的无菌检测

2018-11-05

现行

AAMI/ISO 11737-2-2019

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
医疗器械的灭菌.微生物学方法.第2部分:在灭菌过程的定义、验证和维护中进行的无菌试验

2019-07-11

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