ISO 18113-5:2022
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments 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) 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.
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 18113-5:2024 | Identical |
| DS/EN ISO 18113-5:2024 | Identical |
| SN EN ISO 18113-5:2024 | Identical |
| DS/ISO 18113-5:2022 | Identical |
| UNI EN ISO 18113-5:2024 | Identical |
| ÖNORM EN ISO 18113-5:2024 10 01 | Identical |
| SS-EN ISO 18113-5:2024 | Identical |
| PNE-prEN ISO 18113-5 | Identical |
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