ISO 16061:2021

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

Publication date:   Mar 15, 2021

General information

60.60 Standard published   Mar 15, 2021

ISO

ISO/TC 150 Implants for surgery

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics | 11.040.99   Other medical equipment

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 16061:2015

NOW

PUBLISHED
ISO 16061:2021
60.60 Standard published
Mar 15, 2021