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Стерилизация медицинских изделий. Микробиологические методы. Часть 2. Испытания на стерильность, проводимые при валидации процессов стерилизации
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2011-11-29

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

의료기기의 멸균 — 미생물학적 방법 — 제2부: 멸균 공정의 정의, 유효성 확인 및유지에서 수행되는 멸균확인 시험
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2018-11-05

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

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

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

STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 3: GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES.
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无菌医疗器械包装试验方法　第1部分：加速老化试验指南
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PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 1: GENERAL REQUIREMENTS AND TEST METHODS.
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1997-11-28

最终灭菌医疗器械包装材料　第1部分：吸塑包装共挤塑料膜　要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods

2011-12-31