ISO 14155-2:2003
Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans
Media and price
| Language | Format | Add to basket |
|---|---|---|
| English | PDF (287 kB) | CHF 66,00 |
| English | Paper | CHF 66,00 |
General information
Number of Pages: 9
| Edition: 1 (Monolingual) | ICS: 11.100.20 |
| Status: Published | Stage: 90.92 (2004-06-28) |
| TC/SC: TC 194 |
Abstract
1 Scope
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.
Corrigenda, Amendments and other parts
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