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DANSK DS/EN ISO 18113-3 [ Revised ]

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use

standard by Dansk Standard , 01/15/2010

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Full Description

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.

 

Product Details

Edition:
10
Published:
01/15/2010
Number of Pages:
26
File Size:
1 file , 1.1 MB
Product Code(s):
DS-026, DS-026
 

Document History

  1. DANSK DSF/PREN ISO 18113-3


    In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)

    • Historical Version

  2. DANSK DS/EN ISO 18113-3


    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use

    • Most Recent

  3. DANSK DS/EN ISO 18113-3

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    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use

    • Historical Version