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  • BSI
    BS EN ISO 16061:2021 - TC Tracked Changes. Instruments for use in association with non-active surgical implants. General requirements
    Edition: 2021
    $466.58
    / user per year

Description of BS EN ISO 16061:2021 - TC 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.



Standard NumberBS EN ISO 16061:2021 - TC
TitleTracked Changes. Instruments for use in association with non-active surgical implants. General requirements
StatusDefinitive
Publication Date2021-11-09
ReplacesBS EN ISO 16061:2015 - TC
DescriptorsSurgical equipment, Selection, Stainless steels, Inspection, Chemical composition, Packaging, Design, Compositional tolerances, Ferritic steels, Grades (quality), Martensitic steels, Austenitic steels, Performance, Medical instruments, Implants (surgical), Surgical instruments, Production, Sterilization (hygiene), Instructions for use, Precipitation hardening
ICS11.040.99 Other medical equipment, 11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150
ISBN978 0 539 19906 2
PublisherBSI
Pages64

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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