Standard

ISO 18113-4:2009

Dec 2009 Withdrawn

Note: Latest version: ISO 18113-4:2022

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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.

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Standard from ISO
Published: December 17 2009
Withdrawn: October 6 2022
Period for objection until: April 18 2007
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.10
International TC: ISO/TC 212

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Revised by: ISO 18113-4:2022
Adopted by: SN EN ISO 18113-4:2012
Adopted by: NF EN ISO 18113-4:2012
Adopted by: SN EN ISO 18113-4:2010
Adopted by: NF EN ISO 18113-4:2010

ISO 18113-4:2009

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ISO 18113-4:2022

ISO 18113-4:2009

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ISO 18113-4:2022

ISO 18113-4:2009

Abstract

Products specifications

Product Relations

Product life cycle