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ISO

ISO/TC 194/WG 5 - Cytotoxicity

Cytotoxicité

General Information

Status
Active
Parent
ISO/TC 194 - Biological and clinical evaluation of medical devices
Standardization Organization
ICS
Directive
Mandate
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ISO
ISO 10993-5:2009(Main)
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

  • Standard
    34 pages
    English language
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  • Standard
    34 pages
    French language
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ISO
ISO 10993-5:1999(Main)
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • Standard
    8 pages
    English language
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  • Standard
    8 pages
    French language
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ISO
ISO 10993-5:1992(Main)
Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
  • Standard
    7 pages
    English language
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  • Standard
    7 pages
    French language
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Frequently Asked Questions

ISO/TC 194/WG 5 is a Working Group within the International Organization for Standardization (ISO). It is named "Cytotoxicity". This committee has published 3 standards.

ISO/TC 194/WG 5 develops ISO standards. Currently, there are 3 published standards from this working group.

The International Organization for Standardization (ISO) is an independent, non-governmental international organization that develops and publishes international standards. Founded in 1947 and headquartered in Geneva, Switzerland, ISO brings together experts from 170+ member countries to share knowledge and develop voluntary, consensus-based standards that support innovation and provide solutions to global challenges.

A Working Group in ISO is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.