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Medical Devices Radiation Sterilization

Standards in this category are focused on radiation sterilization with medical devices. There are several series of standards for radiation as well as others that focus on guidance measures.

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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 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.

ISO 11137-1:2006 does not:

  • specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
  • detail specified requirements for designating a medical device as sterile;
  • specify a quality management system for the control of all stages of production of medical devices;
  • specify requirements for occupational safety associated with the design and operation of irradiation facilities;
  • specify requirements for the sterilization of used or reprocessed devices.


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.


ISO 11137-3:2017

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control

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.


ISO/TS 13004:2013

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.


AAMI TIR35:2016

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits.

Describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL). This approach addresses sampling plans for verification dose experiments and sterilization dose audits. In addition the approaches to adopting a product into an established product family are defined.


AAMI TIR37:2013 (AAMI TIR 37:2013)

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products

This technical information report (TIR) provides guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products


AAMI TIR40:2018

Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2

This technical information report describes the approach for establishing a sterilization dose utilizing a modification of the fraction positive, incremental dosing method defined in Method 2 of ANSI/AAMI/ISO 11137-2. 


AAMI TIR63:2014 (R2017)

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine

This technical information report identifies the necessary steps to effectively manage medical devices not owned by the health care facility in which they are used.


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