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EN ISO 16061:2009 Standard

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  Keywords:

#instruments #standard #international #systems #driven

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)

  Purpose

This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 16061:2008"

Anyway is still possible use the "EN ISO 16061:2008" until February 28th, 2010

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EN ISO 8359:2009

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EN ISO 8359:2009/A1:2012

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Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

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