BS EN ISO 18113-2:2024
Current
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
12-06-2024
Publisher
€263.42
Excluding VAT
| 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 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.
| Standards | Relationship |
| ISO 18113-2:2022 | Identical |
| EN ISO 18113-2:2024 | Equivalent |
| I.S. EN ISO 18113-2:2024 | Equivalent |
| DIN EN ISO 18113-2:2024-10 | Equivalent |
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