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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 14th of April 2021

  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 25539-2:2009/AC:2011

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EN ISO 10993-13:2010

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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

EN 13060:2014

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Small steam sterilizers

EN ISO 12870:2009

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Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)

EN ISO 11810-2:2009

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

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...

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