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 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

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

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 0681.11-2014

无菌医疗器械包装试验方法　第11部分：目力检测医用包装密封完整性
Test methods for sterile medical device package—Part 11:Determining integrity of seals for medical packaging by visual inspection

2014-06-17

现行

YY/T 0681.17-2019

无菌医疗器械包装试验方法　第17部分：透气包装材料气溶胶过滤法微生物屏障试验
Test methods for sterile medical device package—Part 17:Testing the microbial barrier performance of porous package materials using aerosol filtration method

2019-10-23

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 0681.5-2010

无菌医疗器械包装试验方法　第5部分：内压法检测粗大泄漏(气泡法)
Test methods for sterile medical device package—Part 5:Detecting gross leaks in medical packaging by internal pressurization(bubble test)

2010-12-27

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

YY/T 0681.3-2010

无菌医疗器械包装试验方法　第3部分：无约束包装抗内压破坏
Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages

2010-12-27

现行

YY/T 0681.10-2011

无菌医疗器械包装试验方法　第10部分：透气包装材料微生物屏障分等试验
Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material

2011-12-31

现行

YY/T 0681.18-2020

无菌医疗器械包装试验方法　第18部分：用真空衰减法无损检验包装泄漏
Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method

2020-03-31

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

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

YY/T 0681.8-2011

无菌医疗器械包装试验方法　第8部分：涂胶层重量的测定
Test methods for sterile medical device package—Part 8:Coating/adhesive weight determination

2011-12-31

现行

YY/T 0681.4-2021

无菌医疗器械包装试验方法　第4部分：染色液穿透法测定透气包装的密封泄漏
Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration

2021-03-09

现行

UNE-EN 868-1-1997

PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 1: GENERAL REQUIREMENTS AND TEST METHODS.
待灭菌医疗器械的包装材料和系统 第1部分:一般要求和试验方法

1997-11-28