EVS-EN ISO/IEC 17030:2021

Conformity assessment - General requirements for third-party marks of conformity (ISO/IEC 17030:2021)

Kehtiv alates 01.10.2021
EN ISO/IEC 17030:2021; ISO/IEC 17030:2021
Direktiivid või määrused
Standardi ajalugu

This document provides general requirements for third-party marks of conformity, including their issue and use. This document covers third-party marks of conformity issued and used in different forms and various media including digital representation employing electronically stored and displayed marks, machine readable code, blockchain (distributed ledger) or other electronic means. NOTE 1 This document can also be used as guidance in using marks of conformity in other than third-party conformity assessment activity. NOTE 2 Third-party marks of conformity according to this document include symbols of recognition such as accreditation symbols. For consistency of terminology in this document they are referred to as accreditation marks. NOTE 3 Third-party marks of conformity according to this document can include logos (e.g. the sign of a conformity assessment body or trademarks), symbols (e.g. the representation of recognition in an accreditation agreement or the depiction of the applicable programme) or a combination thereof. NOTE 4 Third-party marks of conformity as a graphic representation of demonstrated conformity according to this document can be a combination of multiple marks (e.g. indications of compliance with several sets of specifications, codes for individually fulfilled specifications). NOTE 5 This document does not apply to markings, which provide indication of a designation, a code, or a classification only. Furthermore, it does not apply to graphic representations (e.g. of conformity assessment systems or schemes/programmes), logos (e.g. association of accreditation bodies and association of conformity assessment bodies). NOTE 6 third party mark of conformity are based on a conformity assessment scheme that include the function of surveillance.

9,61 € koos KM-ga
9,61 € koos KM-ga
Hind: 2,40 € koos KM-ga
Standardi monitooring
Teised on ostnud veel

EVS-EN ISO 14971:2019

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 02.01.2020
Põhitekst + muudatus

EVS-EN 62304:2006+A1:2015

Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid
Uusim versioon Kehtiv alates 15.11.2019
Põhitekst + muudatus

EVS-EN ISO 13485:2016+A11:2021

Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded
Uusim versioon Kehtiv alates 16.09.2021

EVS-EN ISO 15223-1:2021

Meditsiiniseadmed. Tootjainfos kasutatavad tingmärgid. Osa 1: Üldnõuded
Uusim versioon Kehtiv alates 01.10.2021