Norm

ISO/DIS 11737-1:2016 en

Sterilisatie van medische hulpmiddelen - Microbiologische methodes - Deel 1: Bepaling van de populatie van micro-organismen op producten

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Over deze norm

Status Ontwerp
Aantal pagina's 68
Gepubliceerd op 28-09-2016
Taal Engels
This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. This part of ISO 11737 does not specify requirements or provide guidance for 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. 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 microbiological monitoring of the environment in which health care products are manufactured.

Details

ICS-code 07.100.10
11.080.01
Nederlandse titel Sterilisatie van medische hulpmiddelen - Microbiologische methodes - Deel 1: Bepaling van de populatie van micro-organismen op producten
Engelse titel Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on product
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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