EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

Publication date:   Jul 15, 2021

General information

60.60 Standard published   Mar 31, 2021

CEN

CEN/TC 285 Non-active surgical implants

European Norm

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

Buying

Published

Language in which you want to receive the document.

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

Replaces
EN ISO 16061:2015

NOW

PUBLISHED
EN ISO 16061:2021
60.60 Standard published
Mar 31, 2021