ISO 18113-2:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
OVERVIEW
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.
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 self-testing.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2022 |
| No. of Pages | 11 |
| ICS Classification | 11.100.10 In vitro diagnostic test systems |
| Committee | ISO/TC 212 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |