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EN ISO 10993-14:2009 Standard

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  Keywords:

#part #address #chemical #analysis #solutions

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

  Purpose

This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics(including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions inorder to identify the degradation products. Because of the generalized nature of this part of ISO 10993, productspecific standards, when available, that address degradation product formation under more relevant conditions ofuse, should be considered first.This part of ISO 10993 considers only those degradation products generated by a chemical dissociation ofceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It isnoted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis ofdegradation products.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-14:2001"

Anyway is still possible use the "EN ISO 10993-14:2001" until March 21st, 2010

  Related Standards

EN 13726-1:2002

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EN ISO 10993-7:2008/AC:2009

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10524-2:2006

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Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

EN ISO 10524-3:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

EN ISO 10524-4:2008

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

EN ISO 10555-1:2009

Medical devices Directive (93/42/EEC)

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

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