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ISO 16061:2021

Current Revision

Instruments for use in association with non-active surgical implants - General requirements

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 16061
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 150
Publish Date Document Id Type View
Not Available ISO 16061:2021 Revision
Not Available Revision