SS-EN-ISO-18113-1 › In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
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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 a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 18113-1:2011
Revision Level
2011 EDITION
Status
Current
Publication Date
Nov. 21, 2011
Language(s)
English
Page Count
68
International Equivalent
EN ISO 18113-1:2011(IDT); ISO 18113-1:2009(IDT)