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EN 12006-2:1998+A1:2009 Standard

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  Keywords:

#implants #cardiac #segments #cardio #system

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

  Purpose

This standard describes specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 12006-2:1998"

  Related Standards

EN ISO 13485:2016/AC:2016

Medical devices Directive (93/42/EEC)

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EN ISO 25539-1:2009/AC:2011

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Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

EN 60601-1-8:2007

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EN 60601-1-4:1996

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EN 60601-1-3:2008/AC:2010

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Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Ra...

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