Sterilization of health care products. Microbiological methods Determination of a population of microorganisms on products

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

18-06-2021

Publisher

British Standards Institution

This document 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.

NOTE1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.

NOTE2 See AnnexA for guidance on Clauses1 to 9.

This document 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.

NOTE3 Guidance on inactivating viruses and prions can be found in ISO22442‑3, ICHQ5A(R1) and ISO13022.

This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Committee	CH/198
DocumentType	Standard
ISBN	9780539024234
Pages	70
ProductNote	THIS STANDARD IS ALSO REFERES TO:-IEC 17025,BS EN ISO 1589:2012. Implementation of ISO amendment 1:2021 with CEN endorsement A1:2021 and updating of Annexes ZA and ZB
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 11737-1:2006 BS EN ISO 11737-1:2018