ISO 18113-4:2022
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
06-10-2022
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| DocumentType |
Standard
|
| Pages |
11
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ÖNORM EN ISO 18113-4:2024 10 01 | Identical |
| DS/EN ISO 18113-4:2024 | Identical |
| DS/ISO 18113-4:2022 | Identical |
| NF EN ISO 18113-4:2024 | Identical |
| SN EN ISO 18113-4:2024 | Identical |
| UNI EN ISO 18113-4:2024 | Identical |
| SS-EN ISO 18113-4:2024 | Identical |
| PNE-prEN ISO 18113-4 | Identical |
| PN-EN ISO 18113-4:2024-12 | Identical |
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