STANDARD

Current

ÖNORM EN ISO 11737-1

Issue date: 2021 11 01

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021) (consolidated version)

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.

General information on ÖNORM EN ISO 11737-1

Format
Digital | 74 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 11737-1 from 1996 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 10012:2003
Titel
Measurement management systems — Requirements for measurement processes and measuring equipment
Ausgabedatum
2003 04 14
Art
Standard
Dokumentnummer
ISO 13485:2016
Titel
Medical devices — Quality management systems — Requirements for regulatory purposes
Ausgabedatum
2016 02 25
Art
Standard
Dokumentnummer
ISO 15189:2012
Titel
Medical laboratories — Requirements for quality and competence
Ausgabedatum
2012 11 05
Art
Standard
Dokumentnummer
ISO/IEC 17025:2017
Titel
General requirements for the competence of testing and calibration laboratories (Corrected version 2017-11)
Ausgabedatum
2017 11 29
Art
Standard

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