可重复使用医疗器械灭菌过程有效性的试验方法
Test method of effectiveness of sterilization processes for reusable medical devices
2018-09-21
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 validation of a sterilization process
2018-03-15
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
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
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
YY/T 1402-2016
医疗器械蒸汽灭菌过程挑战装置适用性的测试方法
Test method to demonstrate the suitability of the process challenge device(PCD) during steam sterilization
2016-03-23
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
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
UNE-EN 868-8-2009
Packaging for terminally sterilized medical devices - Part 8: 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.第8部分: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
2009-12-02
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
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
BS EN 868-7-2017
Packaging for terminally sterilized medical devices-Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
最终灭菌医疗器械的包装
2017-02-28
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
UNE-EN 868-7-2009
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
最终灭菌医疗器械的包装.第7部分:低温灭菌过程用胶粘剂涂布纸.要求和试验方法
2009-12-02
YY/T 0698.6-2009
最终灭菌医疗器械包装材料 第6部分：用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 6:Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods