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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 10993-15:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and allo...

EN 20594-1:1993/A1:1997

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Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (...

EN ISO 5360:2009

Medical devices Directive (93/42/EEC)

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

EN 1707:1996

Medical devices Directive (93/42/EEC)

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

EN 1642:2011

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Dental implants

EN 1641:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Materials

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