Status : Withdrawn

This standard has been revised by ISO 16061:2021

Abstract

ISO 16061:2015 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, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.

This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.

General information

  • Status
     : Withdrawn
    Publication date
     : 2015-05
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 3
    Number of pages
     : 19
  • Technical Committee :
    ISO/TC 150
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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