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

ISO 11737-1 is a sterilization standard that specifies requirements and provides guidance on the enumeration and microbial characterization of microorganisms on healthcare products. A sterile healthcare product is free of viable microorganisms. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones.

Sterilization is an example of such a process where the effectiveness of the process cannot be fully verified by inspection and testing. For this reason, sterilization processes are validated for use, the performance of the sterilization process is monitored routinely and the equipment is maintained. The term “bioburden” is used to describe the population of viable microorganisms present in a product. Bioburden is the sum of the microbial contributions from several sources like raw materials, manufacturing environment, cleaning processes and packaging.

ISO 11737-1 specifies the requirements to be met for the determination of bioburden. In addition, it gives guidance to provide explanations and methods that are deemed suitable to conform with the requirements. The main text and the amendment can be found separately in the standard’s history.

In this consolidated version you can find:

— Relationship between EN ISO 11737-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/745

— Relationship between EN ISO 11737-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/746