ISO 14155:2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 — Good clinical practice
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21-01-2011
09-04-2025
ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ISO 14155:2011 does not apply to in vitro diagnostic medical devices.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
Supersedes ISO 14155-1 and ISO 14155-2. (01/2011) DRAFT ISO/DIS 14155 is also available for this standard. (05/2018)
|
| DocumentType |
Standard
|
| Pages |
61
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| GOST R ISO 14155 : 2014 | Identical |
| NF EN ISO 14155 : 2012 | Identical |
| NBN EN ISO 14155 : DEC 2011 | Identical |
| NEN EN ISO 14155 : 2011 C1 2011 | Identical |
| NS EN ISO 14155 : 2011 AC 2011 | Identical |
| I.S. EN ISO 14155:2011 | Identical |
| PN EN ISO 14155 : 2012 | Identical |
| NEN-EN-ISO 14155:2011 | Identical |
| SS-EN ISO 14155:2011 | Identical |
| EN ISO 14155:2011 | Identical |
| BS EN ISO 14155:2011 | Identical |
| DIN EN ISO 14155:2012-01 | Identical |
| IS/ISO 14155 : 2011 | Identical |
| DS EN ISO 14155 : 2012 | Identical |
| UNE-EN ISO 14155:2011 | Identical |
| UNE-EN ISO 14155:2012 | Identical |
A newer version of this standard is available.
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