SS ISO 11737-1 - 2018+A1:2021
Sterilisation of health care products – Microbiological methods – Part 1 : Determination of a population of microorganisms on products
OVERVIEW
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.
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.
This document does not apply to the microbiological monitoring of the environment in which health
care products are manufactured.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2021 |
| No. of Pages | 65 |
| ICS Classification | 11.080.01 Sterilization and disinfection in general 07.100.10 Medical microbiology |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 11737-1 : 2018 IDT |