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BSI BS EN ISO 18113-1:2011

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) -- Terms, definitions, and general requirements
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BSI BS EN ISO 18113-1:2011

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) -- Terms, definitions, and general requirements

PUBLISH DATE 2012
PAGES 62
BSI BS EN ISO 18113-1:2011

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.

This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations.

This part of ISO 18113 does not apply to

  1. IVD devices for performance evaluation (e.g., for investigational use only),

  2. instrument marking,

  3. material safety data sheets.

SDO BSI: British Standards Institution
Document Number ISO 18113-1
Publication Date Jan. 31, 2012
Language en - English
Page Count 62
Revision Level
Supercedes
Committee CH/212
Publish Date Document Id Type View
June 12, 2024 BS EN ISO 18113-1:2024 Revision
Feb. 28, 2010 BS EN ISO 18113-1:2009 Revision
Dec. 7, 2006 BS ISO 18113-1:2006 Revision
Jan. 31, 2012 BS EN ISO 18113-1:2011 Consolidated