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BSI BS EN ISO 16061:2021

Instrumentation for use in association with non-active surgical implants. General requirements
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BSI BS EN ISO 16061:2021

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

PUBLISH DATE 2021
PAGES 24
BSI BS EN ISO 16061:2021

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 BSI: British Standards Institution
Document Number ISO 16061
Publication Date April 6, 2021
Language en - English
Page Count 24
Revision Level
Supercedes
Committee CH/150
Publish Date Document Id Type View
April 6, 2021 BS EN ISO 16061:2021 Revision
May 31, 2015 BS EN ISO 16061:2015 Revision
Dec. 31, 2009 BS EN ISO 16061:2009 Revision
May 31, 2009 BS EN ISO 16061:2008 Revision