DIN EN ISO 18113-5
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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| Organization: | DIN |
| Publication Date: | 1 January 2013 |
| Status: | active |
| Page Count: | 18 |
| 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 instruments for self-testing.
This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
This part of ISO 18113 can also be applied to accessories.
This part of ISO 18113 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.
Document History
September 1, 2021
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021
A description is not available for this item.
DIN EN ISO 18113-5
January 1, 2013
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.
This part of ISO 18113 also applies to apparatus and equipment...
May 1, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
A description is not available for this item.