prSRPS EN ISO 11737-1:2024

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

Scope

ISO 11737-1:2018 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.

NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.

NOTE 2 See Annex A for guidance on Clauses 1 to 9.

ISO 11737-1:2018 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.

NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.

ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.