International Standard
ISO 16061:2021
Instruments for use in association with non-active surgical implants — General requirements
Reference number
ISO 16061:2021
Edition 4
2021-03
International Standard
Read sample
ISO 16061:2021
74548
Published (Edition 4, 2021)

ISO 16061:2021

ISO 16061:2021
74548
Language
Format
CHF 96
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Abstract

This document specifies the 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 supplied after refurbishment.

NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.

This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.

With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

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

General information

  •  : Published
     : 2021-03
    : International Standard published [60.60]
  •  : 4
     : 14
  • ISO/TC 150
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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