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EN ISO 18113-1:2011 Standard

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  Keywords:

#part #ivd #instrument #use #investigational

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

  Purpose

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 18113-1:2009"

Anyway is still possible use the "EN ISO 18113-1:2009" until April 30th, 2012

  Related Standards

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EN ISO 23640:2015

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In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

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