SS-EN-ISO-18113-5 › In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for professional use.
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 18113-5:2011
Revision Level
2011 EDITION
Status
Current
Publication Date
Nov. 21, 2011
Language(s)
English
Page Count
24
International Equivalent
EN ISO 18113-5:2011(IDT); ISO 18113-5:2009(IDT)