Need help?

EN ISO 14630:2009 Standard

wave
Save  

  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 1820:2005+A1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

EN 1641:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Materials

EN ISO 22442-1:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

EN ISO 22442-2:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-...

EN IEC 60118-13:2020

Medical devices Directive (93/42/EEC)

Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital ...

EN ISO 5361:2016

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

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

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0