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eLibrary > BS EN ISO 11737-2:2020 Sterilization of health care products. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process >

BS EN ISO 11737-2:2020 Sterilization of health care products. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process, 2020

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BS EN ISO 11737-2:2020 Sterilization of health care products. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process, 2020

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Annex ZA (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices [OJ L 189] aimed to be covered
Annex ZB (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be covered
Annex ZC (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L 331] aimed to be covered
Annex ZD(informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
Annex ZE(informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Selection of product
5.1 General
5.2 Sample item portion (SIP)
5.3 Packaging of product and sample item portions
6 Methods for performing tests of sterility
7 Assessment of the method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process
Annex B (informative) Typical assignment of responsibilities
Bibliography [Go to Page]

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BS EN ISO 11737-2:2020 Sterilization of health care products. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process, 2020

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