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ISO 16061:2021

Instruments for use in association with non-active surgical implants — General requirements
15. 3. 2021.

Опште информације

60.60     15. 3. 2021.

ISO

ISO/TC 150

Međunarodni standard

11.040.40     11.040.99  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 16061:2015

TRENUTNO

OBJAVLJEN
ISO 16061:2021
60.60 Standard objavljen
15. 3. 2021.

Nacionalna preuzimanja

SRPS EN ISO 16061:2021  
ISS

Instrumenti koji se koriste zajedno sa neaktivnim hirurškim implantatima – Opšti zahtevi

60.60   Standard objavljen

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