DS/EN ISO 16061:2021

Instrumenter til anvendelse i forbindelse med ikke-aktive kirurgiske implantater – Generelle krav


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 454,00
Lovgivning:

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Beskrivelse

This document specifies 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 does not apply to the power-driven systems themselves.
With regard to safety, this document gives 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.


Antal sider: 28

Udgivet: 2021-04-08

Godkendelsesdato: 2021-04-06

Internationale relationer : EN ISO 16061:2021 IDT ISO 16061:2021 IDT

ICS: 11.040.40 - Implantater til kirurgi, protetik og ortoptik 11.040.99 - Andet medicinsk udstyr

Varenummer: M340072


Udvalg og komiteer

Komite

  • CEN/TC 285
  • ISO/TC 150
  • ISO/TC 150/WG 7

Dansk udvalg

DS/S-160