New project
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 11137-2
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 11137-2
Edition 4
New project
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 11137-2
90093

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½± 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. Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

General information

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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