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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 5th of January 2022

  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 22442-2:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-...

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 10993-23:2021

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

EN 60601-1-6:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Us...

EN ISO 25539-2:2009/AC:2011

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

EN ISO 25539-2:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

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