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

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:
  • Dose setting to obtain and product-specific dose.
  • Dose substantiation to verify a preselected dose of 15 kGy, 25.0 kGy.
  • Dose substantiation to verify a preselected dose of 17.5 kGy, 20 kGy, 22.5. kGy, 27.5 kGy, 30 kGy, 32.5 kGy and 35 kGy as per ISO 13004.
• It specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
• It defines product families for establishing sterilization doses and gives details on a sterilization dose audit.
• It complements BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices, BS EN ISO 11137-3:2017 Sterilization of health care products. Radiation - Guidance on dosimetric aspects of development, validation and routine control, and PD ISO/TS 11137-4:2020 Sterilization of health care products. Radiation - Guidance on process control.
• ISO 11137-2 can also help users develop their expertise, increase trust and strengthen risk management

What’s new about ISO 11137-2 - Radiation doses for sterilization of healthcare products?

BS EN ISO 11137-2:2015+A1:2023 is an amendment to BS EN ISO 11137-2:2013. The major changes in BS EN ISO 11137-2:2015+A1:2023 are:

• It adds Method VDmax doses currently in PD CEN ISO/TS 13004:2014 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD.
• It updates normative references.
• It adds Annex ZA and Annex ZB to show the relationship with the new Medical Device Regulation and the In Vitro Diagnostic Regulation.