BS EN ISO 11137-2:2015+A1:2023
Sterilization of health care products. Radiation - Establishing the sterilization dose

Standard No.

BS EN ISO 11137-2:2015+A1:2023

Release Date

2023

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 11137-2:2015+A1:2023

Scope

What is ISO 11137-2 - Establishing the sterilization dose of healthcare products about? This international standard is the second in a four-part series on the sterilization of heath care products using radiation. BS EN ISO 11137-2:2015+A1:2023  covers how to establish the minimum sterilization dose. Part 1 covers requirements for development, validation and routine control of a sterilization process. Part 3 gives guidance on dosimetric aspects. Part 4 gives guidance on control of irradiation processes.   Who is ISO 11137-2 - Radiation doses for sterilization of healthcare products for? Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Healthcare facilities/hospitals What does ISO 11137-2 - Establishing the sterilization dose of healthcare products cover? 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 . The standard also references methods for substantiating pre-selected doses in addition to 15kGy and 25kGy per ISO 13004. ISO 11137-2 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose and defines product families for sterilization dose establishment and sterilization dose audit. Why should you use ISO 11137-2 - Radiation doses for sterilization of healthcare products ? ISO 11137-2 offers three approaches to establishing the sterilization dose: D...

BS EN ISO 11137-2:2015+A1:2023 Referenced Document

• ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
• ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

BS EN ISO 11137-2:2015+A1:2023 history

• 2023 BS EN ISO 11137-2:2015+A1:2023 Sterilization of health care products. Radiation - Establishing the sterilization dose
• 2015 BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation. Establishing the sterilization dose
• 2006 BS EN ISO 11137-1:2006+A1:2013 Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
• 0000 BS EN ISO 11137-1:2006
• 1994 BS EN 552:1994 Sterilization of medical devices - Validation and routine control of sterilization by irradiation