BS EN ISO 18113-5:2024
Current
The latest, up-to-date edition.
Part 5: In vitro diagnostic instruments for self-testingIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)
Hardcopy , PDF
English
31-07-2024
| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| EN ISO 18113-5:2024 | Equivalent |
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