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

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

UNE-EN ISO 11737-2-2010

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
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（ISO 11737-2-2009）

2010-05-05

现行

KS P ISO 11737-1

의료기기의 멸균 — 미생물학적 방법 — 제1부: 제품상의 미생물군의 평가
医疗器械灭菌 - 微生物方法 - 第1部分:产品中微生物群体的测定

2018-11-05

现行

AAMI/ISO 11737-1-2018

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
医疗器械的灭菌.微生物方法.第1部分:产品上微生物种群的测定

2018-01-24

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

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

KS P ISO 11737-2

의료제품의 멸균 — 미생물학적 방법 —제2부: 멸균 공정의 정의, 유효성 확인 및 유지에서 수행되는 멸균 확인 시험
保健产品的灭菌.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

2021-06-28

现行

ISO 11737-2-2019

Sterilization of health care products — 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 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中进行的无菌检测

2019-12-02

现行

YY/T 0681.2-2010

无菌医疗器械包装试验方法　第2部分：软性屏障材料的密封强度
Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials

2010-12-27

现行

UNE-EN ISO 11737-1-2007

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
医疗器械的灭菌.微生物方法.第1部分:产品上微生物种群的测定（ISO 11737-1-2006）

2007-03-14

现行

UNE-EN 1174-3-1997

STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 3: GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES.
医疗器械的消毒 产品上微生物数量的估计 第3部分:微生物技术验证方法指南

1997-04-08

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

YY/T 0681.1-2018

无菌医疗器械包装试验方法　第1部分：加速老化试验指南
Test methods for sterile medical device package—Part 1:Test guide for accelerated aging

2018-12-20

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

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 0681.16-2019

无菌医疗器械包装试验方法　第16部分：包装系统气候应变能力试验
Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system

2019-05-31

现行

YY/T 0681.15-2019

无菌医疗器械包装试验方法　第15部分：运输容器和系统的性能试验
Test methods for sterile medical device package—Part 15:Performance testing of shipping containers and systems

2019-10-23