NEN-EN-ISO 14155-2
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 1 August 2009 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
| ICS Code (Medical equipment in general): | 11.040.01 |
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.
Document History
NEN-EN-ISO 14155-2
August 1, 2009
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
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...
June 1, 2003
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigations plans
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...
July 1, 2001
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigations plans
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...