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DIN EN ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

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Organization: DIN
Publication Date: 1 March 2010
Status: active
Page Count: 50
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

DIN EN ISO 14937
March 1, 2010
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
A description is not available for this item.
DIN EN ISO 14937
May 1, 2001
General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000); English version of DIN EN ISO 14937
A description is not available for this item.

References

This document is referenced by:
DIN EN 1422 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Published by DIN on August 1, 2014
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture...
This document is referenced by:
DIN EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023) (includes Amendment A1:2023)
Published by DIN on February 1, 2024
A description is not available for this item.
This document is referenced by:
DIN EN ISO 80601-2-69 - Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
Published by DIN on December 1, 2014
This particular standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT,...
This document is referenced by:
DIN EN 13060 - Small steam sterilizers (includes Amendment :2018)
Published by DIN on February 1, 2019
This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are...
This document is referenced by:
DIN EN 556-2 - Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte Medizinprodukte; Deutsche Fassung EN 556-2:2015
Published by DIN on November 1, 2015
Diese Europäische Norm legt die Anforderungen an ein aseptisch hergestelltes Medizinprodukt fest, das als „STERIL“ gekennzeichnet wird. ANMERKUNG Für die Anwendung der EU-Richtlinie(n) für...
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