DS/EN ISO 18113-4
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
active, Most Current
Buy Now
| Organization: | DS |
| Publication Date: | 9 December 2011 |
| Status: | active |
| Page Count: | 26 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. ISO 18113-4:2009 can also be applied to accessories, where appropriate. ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.
Document History
DS/EN ISO 18113-4
December 9, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. ISO 18113-4:2009 also applies to information supplied by...
January 15, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)
This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators, and controls intended for self-testing. This document can also be applied to...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
A description is not available for this item.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the...
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)
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...
Related Products
Searching for related products...