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EN 12006-3:1998+A1:2009 Standard

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  Keywords:

#implants #design #evaluation #manufacturing #sterilization

  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 3: Endovascular devices

  Purpose

This European Standard specifies particular requirements for endovascular devices. With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 12006-3:1998"

  Related Standards

EN ISO 21536:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2...

EN ISO 11137-1:2015

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 10993-3:2014

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

EN ISO 10993-4:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10993-5:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 10993-6:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

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