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
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
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...
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