ISO 14155-2:2003
Withdrawn
View Superseded by
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Hardcopy , PDF
English
05-16-2003
03-16-2019
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.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
Supersedes ISO/DIS 14155-2. (05/2003)
|
| DocumentType |
Standard
|
| Pages |
9
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 14155-2:2009-11 | Identical |
| AAMI ISO 14155-2 : 2003 | Identical |
| NF EN ISO 14155-2 : 2009 | Identical |
| GOST R ISO 14155-2 : 2008 | Identical |
| NBN EN ISO 14155-2 : 2009 | Identical |
| NEN EN ISO 14155-2 : 2009 | Identical |
| NS EN ISO 14155-2 : 2009 | Identical |
| I.S. EN ISO 14155-2:2009 | Identical |
| PN EN ISO 14155-2 : 2010 | Identical |
| BS EN ISO 14155-2:2009 | Identical |
| EN ISO 14155-2:2009 | Identical |
| DIN EN ISO 14155-2 E : 2003 | Identical |
| I.S. EN ISO 14155-2:2003 | Equivalent |
| BS EN ISO 14155-2:2003 | Equivalent |
| DIN EN ISO 14155-2:2003-09 | Identical |
| UNE-EN ISO 14155-2:2009 | Identical |
| BS EN ISO 14155-2:2003 | Identical |
| UNE-EN ISO 14155-2:2004 | Identical |
A newer version of this standard is available.
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