ISO 18113-2:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
Synopsis
ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.
General Information
| Status | Current |
|---|---|
| Edition | 2009 |
| No. of Pages | 10 |
| ICS Classification | 11.100.10 In vitro diagnostic test systems |
| Committee | ISO/TC 212 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |
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