GSO ISO 18113-3:2016
ISO 18113-3:2009
Gulf Standard
Historical
·
Approved on
22 December 2016
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
GSO ISO 18113-3:2016 Files
Arabic
12 Pages
Historical
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English
9 Pages
Historical
Reference Language
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GSO ISO 18113-3:2016 Scope
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use.
This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
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 self-testing.
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