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EN ISO 10993-11:2018 Standard

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  Keywords:

#biological #evaluation #medical #devices #part

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

  Publication

Wednesday 25th of March 2020

  Related Standards

EN ISO 13408-2:2011

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

EN 45502-2-2:2008

Active implantable medical devices Directive (90/385/EEC)

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...

EN ISO 11140-1:2009

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

EN ISO 11607-1:2009

Active implantable medical devices Directive (90/385/EEC)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 11737-1:2006

Active implantable medical devices Directive (90/385/EEC)

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

EN ISO 11737-1:2006/AC:2009

Active implantable medical devices Directive (90/385/EEC)

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

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