Tagasi

ISO 16061:2021

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

Üldinfo
Kehtiv alates 15.03.2021
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.03.2021
Põhitekst
11.05.2015
Põhitekst
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.
*
*
*
PDF
97,78 € koos KM-ga
Paber
97,78 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst + muudatus

EVS-EN 62366-1:2015+A1:2020

Meditsiiniseadmed. Osa 1: Kasutatavusprojekteerimise rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 17.08.2020
Põhitekst

EVS-EN ISO 22081:2021

Geometrical product specifications (GPS) - Geometrical tolerancing - General geometrical specifications and general size specifications (ISO 22081:2021)
Uusim versioon Kehtiv alates 15.03.2021