DSF/prEN ISO 18113-3
Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2006)
inactive
| Organization: | DS |
| Status: | inactive |
| 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 professional use.
Furthermore, this part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This part of ISO 18113 can also be applied to accessories, where appropriate.
This part of ISO 18113 does not apply to
a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials, or
c) IVD instruments for self-testing.
Document History
December 19, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and...
January 15, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)
This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for professional use. This document also applies to apparatus and equipment intended to...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)
A description is not available for this item.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment...
DSF/prEN ISO 18113-3
Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2006)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use.
Furthermore, this part of ISO 18113 also applies to apparatus and...