DSF/ISO/DIS 18113-5
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing
pending, Most Current
| Organization: | DS |
| Status: | pending |
| 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 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
DSF/ISO/DIS 18113-5
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 IVD instruments intended for self-testing. This document also applies to apparatus and equipment intended to be...