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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 13795-1:2019

Medical devices Directive (93/42/EEC)

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

EN ISO 7886-3:2009

Medical devices Directive (93/42/EEC)

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

EN ISO 10993-13:2010

Medical devices Directive (93/42/EEC)

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

EN ISO 10993-12:2012

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

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 10993-6:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

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