ISO 14155-2:2003 PDF
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Title (English):
ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 9
- Publication date:
- May 16, 2003
- Edition:
- ISO IS 14155 edition 1 version 1
- ICS:
- 11.100.20
Description (English):
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation. This Standard does not apply to in vitro diagnostic medical devices.
Technical details
- Technical committee
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO 14155-2:2003
