ISO 14155-2:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Hardcopy , PDF
English
16-05-2003
16-03-2019
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Withdrawn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A newer version of this standard is available.
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