ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60 Co or 137 Cs, a beam from an electron generator or a beam from an X-ray generator. ISO 11137-1:2006 does not: specify requirements for the sterilization of used or reprocessed devices.

ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

What is ISO 11137? ISO 11137 is the international standard governing the sterilization of healthcare products using radiation. It’s broken up into three sections that cover every aspect of radiation sterilization for medical device manufacturers:

The ISO 11137 standard is an internationally recognized set of guidelines for the sterilization of healthcare products using radiation. It ensures that medical devices are consistently sterile, safe, and effective at scale. How to develop and validate a sterilization process (ISO 11137-1).

ISO 11137-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11137-2:2006), which has been technically revised. ISO 11137 consists of the following parts, under the general title . Sterilization of health care products — Radiation:

This part of ISO 11137 describes requirements that, if met, will provide a radiation sterilization process intended to sterilize medical devices, that has appropriate microbicidal activity. Furthermore, compliance with the requirements ensures that this activity is both reliable and reproducible so that predictions can be made, with reasonable ...

This part of ISO 11137 describes requirements that, if met, will provide a radiation sterilization process intended to sterilize medical devices, that has appropriate microbicidal activity. Furthermore, compliance with

ISO 11137 is an international standard that deals with the sterilization of healthcare products, particularly focusing on the use of radiation. It consists of multiple parts, each addressing different aspects of the sterilization process using irradiation.