DS/EN ISO 18113-2
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
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| Organization: | DS |
| Publication Date: | 9 December 2011 |
| Status: | active |
| Page Count: | 26 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
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.
Document History
DS/EN ISO 18113-2
December 9, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
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...
January 15, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
This document can also be applied to accessories. This document applies to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)
A description is not available for this item.
Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2006)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use.
Furthermore, this part of ISO 18113 also applies to information...
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the...
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