BS EN ISO 11737-2:2020

What is ISO 11737‑2 - Sterilization of health care products about?  

ISO 11737 discusses the sterilization of health care products using microbiological methods. ISO 11737‑2 outlines criteria for tests of sterility on medical devices that have been exposed to treatment with a sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. 

Tests specified in ISO 11737‑2 are intended to be performed when defining, validating, or maintaining a sterilization process. 

Note: ISO 11737‑2 does not apply to sterility testing for routine release of a product that has been subjected to a sterilization process, performing a test for sterility test of sterility or test for sterility for demonstration of product shelf life, stability, and/or package integrity, and culturing of biological indicators or inoculated products. 

Who is ISO 11737‑2 - Sterilization of health care products for? 

ISO 11737‑2 on the sterilization tests for medical devices with microbiological methods is useful for: 

• Manufacturers and suppliers of health care products 
• Research laboratories 
• Healthcare regulatory authorities 

Why should you use ISO 11737‑2 - Sterilization of health care products? 

A sterile medical device is one that is free from viable microorganisms. When it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device from all sources should be minimized. Sterilization is done to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones. 

ISO 11737‑2 guideline helps you with general requirements, sample item portion (SIP), packaging of the product, methods for performing tests of sterility, assessment of the method for performing tests of sterility, and maintenance of the method for performing tests of sterility. These sterilization tests for medical devices contribute towards safeguarding the health and safety of patients while also prolonging the life of the product.  

What’s changed since the last update? 

BS EN ISO 11737‑2:2020 supersedes ISO 11737‑2:2009, which has been withdrawn. BS EN ISO 11737‑2:2020 has some technical changes with respect to ISO 11737‑2:2009. These includes: 

• Addition of a requirement concerning the test samples and the interval of time between the manufacture of the product and the exposure to the sterilizing agent being as short as possible 
• Addition of a requirement about the samples staying immersed in the culture media and providing a rationale where this is not possible 
• Provision of additional guidance regarding performing tests of sterility on the packaging, clarifying that package testing is not typically done except when it is an integral part of the product 
• Provision of additional guidance regarding what is meant by “controlled environment” for performing tests of sterility 
• Provision of additional guidance to discuss circumstances where the method suitability test does not give acceptable results, stating that after multiple attempts to eliminate inhibitory substances, it is appropriate to accept a reduction of inhibitory substances, with an accompanying rationale and risk assessment