Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2012
Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Edition 2
2012-03
Withdrawn
Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2012
51238
Withdrawn (Edition 2, 2012)

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2011 specifies methods of 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± 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

General information

Got a question?

Check out our Help and Support

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)