Standard

NS-EN ISO 18113-4:2011

Jan 2012 Withdrawn

Note: This standard has a new edition: NS-EN ISO 18113-4:2024

Corrigendums and amendments are bought separately.

Language English

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Abstract

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.ISO 18113-4:2009 can also be applied to accessories, where appropriate.ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Document information

Standard from SN
Published: 1 January 2012
Withdrawn: 26 June 2024
Edition: 2011-10
Version: 1
Document type: NAT
ISBN:

ICS 11.100.10
National Committee SN/K 116

Legal references

EU law: 98/79/EC

Product Relations

Replaced by: NS-EN ISO 18113-4:2024
Referred by: NS-EN ISO 15197:2015
Replaces: NS-EN ISO 18113-4:2009
Adopted from: EN ISO 18113-4:2011 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 18113-4:2009
Current product

Withdrawn

NS-EN ISO 18113-4:2011
Replaced by

Draft

prNS-EN ISO 18113-4:2021

Published

NS-EN ISO 18113-4:2024

NS-EN ISO 18113-4:2011

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NS-EN ISO 18113-4:2024