UNE-EN ISO 11737-1:2018
Current
The latest, up-to-date edition.
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
Hardcopy , PDF
26-12-2018
This part of ISO 11737 specifies requirements and provides guidance for the enumeration andmicrobial characterization of the population of viable microorganisms on or in a health care product,component, raw material or package.NOTE The nature and extent of microbial characterization is dependent on the intended use of the bioburdendata.This part of ISO 11737 does not specify requirements or provide guidance for the enumeration oridentification of viral, prion, or protozoan contaminants. This includes the removal and detection of thecausative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathyand Creutzfeldt-Jakob disease. Guidance on inactivating viruses and prions can be found in ISO 22442-3,ICH Q5A(R1) and ISO 13022.This part of ISO 11737 does not specify requirements or provide guidance for the microbiologicalmonitoring of the environment in which health care products are manufactured.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
78
|
| ProductNote |
THIS STANDARD ALSO IDENTICAL TO EN ISO 11737-1:2018
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 11737-1:2018 | Identical |
| ISO 11737-1:2018 | Identical |
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