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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 21534:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

EN ISO 11138-3:2009

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Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

EN ISO 12870:2009

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Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)

EN ISO 11990-2:2014

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Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-...

EN ISO 11990-1:2014

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Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-...

EN ISO 11979-8:2009

Medical devices Directive (93/42/EEC)

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

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