DSF/prEN ISO 18113-4
Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2006)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 21 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.
Furthermore, this part of ISO 18113 applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
This part of ISO 18113 can also be applied to accessories, where appropriate.
This part of ISO 18113 applies to labels for the outer and immediate container and to the instructions for use.
This part of ISO does not apply to
a) material safety data sheets,
b) information supplied with reagents for performance evaluation (e.g., for investigational use only),
c) IVD instruments or equipment, or
d) IVD reagents for professional use.
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