Standard

SN EN ISO 18113-4:2010

May 2010 Withdrawn

Note: Latest version: SN EN ISO 18113-4:2012

Existing or new amendments and versions must be purchased separately.

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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.

Products specifications

Standard from INB
Published: May 1 2010
Withdrawn: December 31 2012
Effective: May 1 2010
Document type: EN
Pages
ISBN:

ICS: 11.100.10
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 157

Product Relations

Replaced by: SN EN ISO 18113-4:2012
Adopted from: ISO 18113-4:2009, IDT
Replaces: SN EN 376:2002

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (0)

Version history History (3)

SN EN ISO 18113-4:2012