SIST EN ISO 11137-2:2015 PDF
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 81
- Дата публикации:
- 5 августа 2015 г.
- ICS:
- 11.080.01
- Технический комитет:
- VAZ - Healthcare
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Abstract
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