ISO - 18113-4
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
active, Most Current
| Organization: | ISO |
| Publication Date: | 1 October 2022 |
| Status: | active |
| 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 in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable 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
18113-4
October 1, 2022
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 in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also...
December 15, 2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.
This part of ISO 18113 also applies to information supplied by the...