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)
pending
| Organization: | DS |
| Status: | pending |
| Page Count: | 26 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for self-testing. This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing. This document can also be applied to accessories. This document 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.
Document History
December 9, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
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...
January 15, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
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...
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)
This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for self-testing. This document also applies to apparatus and equipment intended to be...
Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2006)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.
Furthermore, this part of 18113 also applies to apparatus, equipment,...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021)
A description is not available for this item.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2009)
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...