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ISO 14937 FRENCH

Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux

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Organization: ISO
Publication Date: 15 October 2009
Status: active
Page Count: 50
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

ISO 14937 FRENCH
October 15, 2009
Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux
A description is not available for this item.

References

This document references:
AAMI ST67 - Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Published by AAMI on January 1, 2019
Inclusions This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as “sterile.” Approaches to...
This document references:
EN 556-1 - Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
Published by CEN on October 1, 2001
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated "STERILE". Part 2 of this European Standard specifies the requirements for an aseptically...
This document references:
IEC 61010-2-040 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
Published by IEC on May 1, 2020
Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical,...
This document references:
ISO 10012 - Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment
Published by ISO on April 15, 2003
This International Standard specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document is referenced by:
SN EN ISO 10451 - Dentistry - Contents of technical file for dental implant systems
Published by SNV on September 1, 2010
This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part...
This document is referenced by:
BS EN 14180 - Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing
Published by BSI on May 31, 2014
A description is not available for this item.
This document is referenced by:
AAMI 81060-1 - Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
Published by AAMI on January 1, 2007
This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood...
This document is referenced by:
SN EN ISO 15378 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
Published by SNV on March 1, 2018
A description is not available for this item.
This document is referenced by:
EN ISO 25539-3 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
Published by CEN on December 1, 2011
This part of ISO 25539 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes,...
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