BS EN ISO 18113-4:2024
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing
Hardcopy , PDF
English
12-06-2024
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
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