BS EN ISO 11737-1:2018+A1:2021

What is ISO 11737-1 - Sterilization of health care products about?  

ISO 11737-1 is the first standard in a series that helps you to determine the success of sterilization by giving guidance on how to count and characterize microorganisms on health care products.  

A sterile healthcare product is one that’s free of viable microorganisms. For sterilization to be successful, the presence and nature of bacteria and other microorganisms needs to be sufficiently estimated. To that end, ISO 11737-1 provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material, or package. 

 ISO 11737-1 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms. These microorganisms may be on or in a health care product, component, raw material, or package.  

ISO 11737-1 also specifies the requirements to be met for the determination of bioburden. Routine determination of bioburden is performed by employing documented sampling plans that specify sample size and sampling frequency. 

NOTE- ISO 11737-1 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease. 

Who is ISO 11737-1 - Sterilization of health care products for? 

ISO 11737-1 on sterilization of health care products is applicable to: 

• Medical facilities / Hospitals 
• Medical device manufacturers 
• Manufacturers of healthcare products 
• Regulatory authorities for healthcare products 
• Other professionals responsible for sterilization 

Why should you use ISO 11737-1 - Sterilization of health care products? 

The purpose of sterilization is to deactivate microbiological contaminants and transform the non-sterile products into sterile ones. ISO 11737-1 provides detailed, authoritative guidance on bioburden testing. This helps you to manage risks. 

ISO 11737-1 helps you to harmonize with the EU’s MDR requirements. ISO 11737-1 also supports use of common terminology in sterilization processes. ISO 11737-1 also helps increase trust in your products. 

What’s changed since the last update? 

ISO 11737-1:2018+A1:2021 supersedes ISO 11737-1:2006 which is withdrawn. ISO 11737-1:2018+A1:2021 includes some technical changes with respect to ISO 11737-1:2006. These include: 

• The term “bioburden spikes” has been introduced as a normal and consistent part of the bioburden, and examples of data have been provided. 
• Clarification has been added that package testing is not typically done except when it is an integral part of the product. 
• More information has been provided on the most probable number (mpn) technique and its applications and details have been provided on ways to improve the limit of detection (lod) and correct use of the data. 
• Some discussion has been deleted of statistical methods for the evaluation of bioburden data where information was not typical or not required. 
• Some discussion has been deleted of statistical methods for the evaluation of bioburden data where information was not typical or not required.