ISO - 18113-5
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
active, Most Current
| Organization: | ISO |
| Publication Date: | 1 October 2022 |
| Status: | active |
| Page Count: | 16 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable 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
18113-5
October 1, 2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus...
December 15, 2009
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...