What is this standard about?
A sterile medical device is one that is free of viable microorganisms. This first part in the BS EN ISO 11737 series specifies the requirements that need to be met to determine the total population of viable microorganisms present.
Who is this standard for?
The medical devices sterilization industry
Why should you use this standard?
It specifies requirements and 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.
What’s changed since the last update?
The main changes compared to the previous edition are as follows:
- 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
- Details have been provided on ways to improve 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
- A table has been added with criteria for selection of a recovery efficiency approach, the use of the correction factor (CF) has been explained, and the recovery efficiency value of < 50 % mentioned for technique modifications has been eliminated
- More information has been provided on the application and performance of a bioburden method suitability test
- A section has been added to detail rules for direct plate counts, estimated counts and counts beyond the ideal range
- A table has been added to clarify where typical responsibilities reside for the manufacturer or the laboratory
- The focus on a risk-based approach has been increased, including the purpose for which bioburden data will be used
