ISO 14155-1:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
26-02-2003
16-03-2019
ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:
- protect human subjects;
- ensure the scientific conduct of the clinical investigation;
- assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
ISO 14155-1:2002
- specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,
- specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,
- is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
Supersedes ISO/DIS 14155-1 (03/2003)
|
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 14155-1:2009-11 | Identical |
| AAMI ISO 14155-1 : 2003 | Identical |
| NF EN ISO 14155-1 : 2009 | Identical |
| GOST R ISO 14155-1 : 2008 | Identical |
| NBN EN ISO 14155-1 : 2009 | Identical |
| NEN EN ISO 14155-1 : 2009 | Identical |
| NS EN ISO 14155-1 : 2009 | Identical |
| I.S. EN ISO 14155-1:2009 | Identical |
| PN EN ISO 14155-1 : 2010 | Identical |
| AS ISO 14155.1-2004 | Identical |
| BS EN ISO 14155-1:2009 | Identical |
| EN ISO 14155-1:2009 | Identical |
| DIN EN ISO 14155-1 E : 2003 | Identical |
| BS EN ISO 14155-1:2003 | Equivalent |
| I.S. EN ISO 14155-1:2003 | Equivalent |
| SS-EN ISO 14155-1:2009 | Identical |
| UNE-EN ISO 14155-1:2003 | Equivalent |
| DIN EN ISO 14155-1:2003-09 | Identical |
| UNE-EN ISO 14155-1:2009 | Identical |
A newer version of this standard is available.
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