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 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.
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO 18113 |
| Publication Date | Oct. 1, 2022 |
| Language | en - English |
| Page Count | |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 212 |
Failed to load document history.
| Publish Date | Document Id | Type | View |
|---|