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EN ISO 14630:2009 Standard

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  Keywords:

#standard #international #tests #materials #design

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Non-active surgical implants - General requirements (ISO 14630:2008)

  Purpose

This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 14630:2008"

Anyway is still possible use the "EN ISO 14630:2008" until March 21st, 2010

  Related Standards

EN 60601-2-46:1998

Medical devices Directive (93/42/EEC)

Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tablesIEC 60601-2-46:1998

EN 60601-2-27:2006

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardi...

EN 60601-2-45:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic...

EN 60601-2-40:1998

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment...

EN 60601-2-39:2008

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysi...

EN 60601-2-36:1997

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotrips...

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CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 14630:2009 STANDARD

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