DSF/ISO/DIS 18113-4
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing
pending, Most Current
| Organization: | DS |
| Status: | pending |
| Page Count: | 18 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators, and controls intended for self-testing. This document can also be applied to accessories. This document applies to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.
Document History
DSF/ISO/DIS 18113-4
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing
This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators, and controls intended for self-testing. This document can also be applied to...