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EN ISO 10993-11:2018 Standard

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  Keywords:

#reactions #materials #cause #adverse #systemic

  Directive

Medical devices Directive (93/42/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)

  Purpose

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN ISO 22442-3:2007

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viru...

EN ISO 10993-11:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

EN ISO 11810-1:2009

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient pro...

EN ISO 11607-1:2009

Medical devices Directive (93/42/EEC)

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

EN ISO 11140-3:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type...

EN ISO 10993-18:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

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