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EN ISO 18113-4:2011 Standard

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  Keywords:

#part #ivd #use #applies #vitro

  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 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

  Purpose

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment, b) IVD reagents for professional use.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 18113-4:2009"

Anyway is still possible use the "EN ISO 18113-4:2009" until April 30th, 2012

  Related Standards

EN 556-1:2001

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

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EN ISO 18113-1:2011

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and genera...

EN ISO 14971:2012

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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN ISO 15193:2009

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In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and pre...

EN ISO 15194:2009

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In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified refer...

EN ISO 15197:2015

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In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitu...

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