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EN ISO 10993-15:2009 Standard

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  Keywords:

#metallic #accelerated #part #applicable #material

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

  Purpose

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying andquantifying degradation products from finished metallic medical devices or corresponding material samples finishedas ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of thefinished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of thesetests, the test results may not reflect the implant or material behavior in the body. The described chemicalmethodologies are a means to generate degradation products for further assessments.This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 10993-15:2000".

Anyway is still possible use the "EN ISO 10993-15:2000" until March 21st, 2010

  Related Standards

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 60601-2-25:1995

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographsIEC 60601-2-25:1993

EN 60601-2-33:2010/A12:2016

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Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic reson...

EN 60601-2-33:2010/AC:2016-03

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Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic reson...

EN 60601-2-33:2010/A2:2015 (IEC 60601-2-33:2010/A2:2015)

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic reson...

EN 60601-2-33:2010/A1:2015 (IEC 60601-2-33:2010/A1:2013)

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic reson...

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