What is BS EN ISO 11737-1:2018+A1:2021 about?
This international standard helps users determine the success of sterilization by giving guidance on how to count and characterize microorganisms on health care products. BS EN ISO 11737-1:2018+A1:2021 is an amendment to the 2018 version.
Who is BS EN ISO 11737-1:2018+A1:2021 for?
- Medical device manufacturers
- Sterilization service providers
- Other professionals responsible for sterilization
What does EN ISO 11737-1:2018+A1:2021 cover?
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, this document 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.
Why should you use EN ISO 11737-1:2018+A1:2021?
Because the standard:
- Supplies detailed, authoritative guidance on bioburden testing
- Aids harmonization with the EU’s MDR requirements
- Supports use of common terminology in sterilization processes
- Helps increase trust in your products
- Helps manage risk
What’s new about BS EN ISO 11737-1:2018+A1:2021?
This amendment contains a revision to formula B.1, an MPN test, in Annex B.3.3.4, that included mistakes in the original publication.