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About This Item

 

Full Description

SAME AS ISO 18113-5

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing. ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. ISO 18113-5:2009 can also be applied to accessories.

 

Amendments, rulings, supplements, and errata

  1. DANSK DSF/FPREN ISO 18113-5


    In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)