ISO 11137-2:2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

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.

SDO:

ISO

Language:

English

ICS Codes:

11.080.01

Status:

Published

Publish date:

2013-05-20

Standard Number:

ISO 11137-2:2013