BS EN ISO 11737-2:2020 PDF

Sterilization of health care products. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Дата публикации:: 31 мая 2020 г.
ICS:: 07.100.10
Технический комитет:: CEN
SKU:: BS EN ISO 11737-2:2020

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Abstract

What is ISO 11737‑2 - Sterilization of health care products about? ISO 11737 discusses the sterilization of health care products using microbiological methods. ISO 11737 ‑ 2 outlines criteria for tests of sterility on medical devices that have been exposed to treatment with a sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. Tests specified in ISO 11737 ‑ 2 are intended to be performed when defining, validating, or maintaining a sterilization process. Note: ISO 11737 ‑ 2 does not apply to sterility testing for routine release of a product that has b...

BS EN ISO 11737-2:2020 PDF

Abstract

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