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Standarder bidrar til FNs bærekraftsmål

Medisinsk utstyr

Det er veldig viktig at høy kvalitet og sikkerhet ivaretas i virksomheter som er involvert i medisinsk utstyr. Internasjonalt er medisinsk utstyr et sentralt standardiseringsområde, og det finnes flere standarder på området.

Standardene omfatter blant annet kvalitetsledelse, koplingsutstyr for væskeleveringssystemer, overvåkingssystemer, symboler og nomenklatura og sanitær tappearmatur.

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Popular standards

ISO 13485:2016

Standard

NOK 3 031,00 (excl. VAT)

Standard

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Medical devices — Quality management systems — Requirements for regulatory purposes

Language: Edition: 3 (2016-02-25)

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NS-EN ISO 15225:2016

Standard

NOK 673,00 (excl. VAT)

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Medisinsk utstyr - Kvalitetsstyring - Nomenklatorisk datastruktur for medisinsk utstyr (ISO 15225:2016)

Language: Edition: 1 (2016-07-01)

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ISO 16142-1:2016

Standard

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Standard

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Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

Language: Edition: 1 (2016-03-09)

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NS-EN ISO 80369-1:2018

Standard

NOK 828,00 (excl. VAT)

Standard

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Forbindelsesstykker med liten diameter for væsker og gass til medisinsk bruk - Del 1: Generelle krav (ISO 80369-1:2018)

Language: Edition: 1 (2019-02-01)

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Monitor standard

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NS-EN ISO 14971:2019

Standard

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Standard

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Medisinsk utstyr — Bruk av risikostyring for medisinsk utstyr (ISO 14971:2019)

Language: Edition: 2019-12 (2020-03-01)

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ISO/TR 24971:2020

Standard

NOK 3 587,00 (excl. VAT)

Standard

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Medical devices — Guidance on the application of ISO 14971

Language: Edition: 2 (2020-06-16)

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ISO/IEC Guide 63:2019

Standard

NOK 2 264,00 (excl. VAT)

Standard

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

Language: Edition: 3 (2019-08-12)

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Monitor standard

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NS-EN ISO 15223-1:2021

Standard

NOK 1 005,00 (excl. VAT)

Standard

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Medisinsk utstyr — Symboler til bruk med informasjon som skal leveres av produsenten — Del 1: Generelle krav (ISO 15223-1:2021)

Language: Edition: 2021-09 (2022-05-05)

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Monitor standard

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