ISO 18113-5:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2022 |
| No. of Pages | 10 |
| ICS Classification | 11.100.10 In vitro diagnostic test systems |
| Committee | ISO/TC 212 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |