ISO 18113-5:2009 PDF
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Open preview (PDF)In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testingIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 8
- Publication date:
- December 9, 2009
- Edition:
- ISO IS 18113 edition 1 version 1
- ICS:
- 11.100.10
ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing. ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. ISO 18113-5:2009 can also be applied to accessories.
Technical details
- Technical committee
- ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
- SKU
- ISO 18113-5:2009


