90.92 Standard to be revised Jan 2, 2024
ISO
ISO/TC 198 Sterilization of health care products
International Standard
11.080.01 Sterilization and disinfection in general | 07.100.10 Medical microbiology
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.
PUBLISHED
ISO 11737-1:2018
90.92
Standard to be revised
Jan 2, 2024
PUBLISHED
ISO 11737-1:2018/Amd 1:2021
IN_DEVELOPMENT
ISO/CD 11737-1