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ISO 13485 FRENCH

Medical devices Quality management systems Requirements for regulatory purposes

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Organization: ISO
Publication Date: 1 March 2016
Status: active
Page Count: 46
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Medical equipment in general): 11.040.01

Document History

ISO 13485 FRENCH
March 1, 2016
Medical devices Quality management systems Requirements for regulatory purposes
A description is not available for this item.
ISO 13485 FRENCH
August 1, 2009
Medical devices — Quality management systems — Requirements for regulatory purposes — TECHNICAL CORRIGENDUM 1
A description is not available for this item.
ISO 13485 FRENCH
July 15, 2003
Medical devices Quality management systems Requirements for regulatory purposes
A description is not available for this item.

References

This document is referenced by:
ISO 14937:11 - 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
Published by CSA on January 1, 2011
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a...
This document is referenced by:
DIN EN ISO 11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
Published by DIN on November 1, 2017
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a...
This document is referenced by:
CSA C22.2 NO 60601-1-6 - Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Published by CSA on January 1, 2015
INTRODUCTION Amendment 1 removes the reference to the complete life-cycle process (including postproduction monitoring and surveillance). IEC 60601 (the series) is confined to performing a TYPE TEST...
This document is referenced by:
ISO 11040-6 - Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
Published by ISO on January 1, 2019
This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for...
This document is referenced by:
11607-1 AMD 1 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems AMENDMENT 1: Application of risk management
Published by ISO on September 1, 2023
A description is not available for this item.
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