Standard Swedish standard · SS-EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Status: Valid

Scope
This part of ISO 11137 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. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

Subjects

Sterilization and disinfection in general (11.080.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Article no: STD-8014811

Edition: 5

Approved: 7/6/2015

No of pages: 88

Replaces: SS-EN ISO 11137-2:2013