DSF/prEN ISO 18113-5
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)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 18 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
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, calibrator and control materials intended to be used with IVD instruments for self-testing.
This part of ISO 18113 can also be applied to accessories, where appropriate.
This part of ISO 18113 does not apply to
a) instructions for instrument servicing or repair,
b) marking of IVD instruments, which is covered in IEC standards,
c) IVD reagents, including calibrators and controls for use in control of the reagent, or
d) 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...
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...
DSF/prEN ISO 18113-5
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...