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EN ISO 21536:2009 Standard

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  Keywords:

#implants #standard #international #design #replacement

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)

  Purpose

This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 21536:2007"

Anyway is still possible use the "EN ISO 21536:2007" until March 21st, 2010

  Related Standards

EN 60601-2-20:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transpo...

EN 1422:1997+A1:2009

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Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

EN ISO 5360:2009

Medical devices Directive (93/42/EEC)

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

EN ISO 5366-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

EN ISO 5840:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

EN ISO 7197:2009

Medical devices Directive (93/42/EEC)

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

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