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BSI BS EN ISO 18113-2:2011

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) -- In vitro diagnostic reagents for professional use
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BSI BS EN ISO 18113-2:2011

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) -- In vitro diagnostic reagents for professional use

PUBLISH DATE 2012
PAGES 24
BSI BS EN ISO 18113-2:2011

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use.

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 professional use.

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

  1. IVD instruments or equipment,

  2. IVD reagents for self-testing.

SDO BSI: British Standards Institution
Document Number ISO 18113-2
Publication Date Jan. 31, 2012
Language en - English
Page Count 24
Revision Level
Supercedes
Committee CH/212
Publish Date Document Id Type View
June 12, 2024 BS EN ISO 18113-2:2024 Revision
Feb. 28, 2010 BS EN ISO 18113-2:2009 Revision
Dec. 7, 2006 BS ISO 18113-2:2006 Revision
Jan. 31, 2012 BS EN ISO 18113-2:2011 Consolidated