Standard

NS-EN ISO 18113-4:2009

Mar 2010 Withdrawn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

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.

Document information

Standard from SN
Published: 1 March 2010
Withdrawn: 1 January 2012
Edition: 1
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 18113-4:2011
Replaces: NS-EN 376:2002
Adopted from: EN ISO 18113-4:2009 , 0

Product life cycle

Previous product

Withdrawn

NS-EN 376:2002
Current product

Withdrawn

NS-EN ISO 18113-4:2009
Replaced by

Withdrawn

NS-EN ISO 18113-4:2011

NS-EN ISO 18113-4:2009

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NS-EN ISO 18113-4:2024

NS-EN ISO 18113-4:2011