EN ISO 18113-4:2009
Withdrawn
Withdrawn
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
Published date
12-15-2009
Publisher
Withdrawn date
12-31-2012
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ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.ISO 18113-4:2009 can also be applied to accessories, where appropriate.ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| I.S. EN ISO 18113-4:2009 | Equivalent |
| BS EN ISO 18113-4:2009 | Equivalent |
| UNE-EN ISO 18113-4:2010 | Identical |
| BS EN ISO 18113-4:2009 | Identical |
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