ISO 18113-4:2009 PDF
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
Open preview (PDF)In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testingIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 10
- Publication date:
- December 17, 2009
- Edition:
- ISO IS 18113 edition 1 version 1
- ICS:
- 11.100.10
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.
Technical details
- Technical committee
- ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
- SKU
- ISO 18113-4:2009
