EVS-EN ISO 11737-1:2018

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 one that 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 a number of 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 international standard has been approved in Europe as EN ISO 11737-1:2018 without any changes and it supersedes EN ISO 11737-1:2006.