ISO 11137-1 Sterilization of Health Care Products - Part 1: Requirements for Improving the Sterilization Process of Medical Devices

Developed by the International Standards Organization (ISO), this part of the ISO 11137 standard specifies requirements for the development, verification and routine control of a radiation sterilization process for medical devices. While the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that can be applied to other products and equipment.

This part of ISO 11137 covers radiation operations using irradiators that use:

• Radionuclide ⁶⁰Co or ¹³⁷Cs
• A beam from an electron generator
• A beam from an X-ray generator

A sterile medical device is one that is free from living microorganisms. International Standards specifying requirements for the validation and routine control of sterilization processes require that incidental microbiological contamination of a medical device prior to sterilization be minimized when a sterile medical device has to be supplied. However, medical devices manufactured under standard manufacturing conditions in accordance with quality management systems requirements (see, for example, ISO 13485) may have a small number of microorganisms on them prior to sterilization. Such medical devices are not sterile. The purpose of sterilization is to neutralize microbiological contaminants and thus render non-sterile medical devices sterile.

This part of ISO 11137 does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been made in certain countries for the handling of materials potentially contaminated with these agents. This part of ISO 11137 does not describe in detail the specified requirements for determining a medical device as sterile.

Having a complete quality management system during production is not a requirement of this part of ISO 11137, but the elements of the quality management system that are the minimum necessary to control the sterilization process are normatively referred to in the text where appropriate (see especially Clause 4). Attention is drawn to quality management systems standards (see ISO 13485), which control all stages of the manufacture of medical devices, including the sterilization process. Regional and national regulations regarding the provision of medical devices may require the implementation of a complete quality management system and its evaluation by a third party.

This part of ISO 11137 does not require the use of biological indicators to verify or monitor radiation sterilization or a pharmacopoeial test for sterility for product release. This part of ISO 11137 does not specify occupational safety requirements for the design and operation of irradiation facilities.

Attention is also drawn to the existence of regulations specifying safety requirements for radiation-related occupational safety in some countries. This part of ISO 11137 does not specify requirements for sterilization of used or reprocessed devices.

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