ISO 11249:2018
Current
The latest, up-to-date edition.
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
01-02-2018
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ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies.
ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.
| Committee |
ISO/TC 157
|
| DevelopmentNote |
Supersedes ISO/DIS 11249. (02/2018)
|
| DocumentType |
Standard
|
| Pages |
23
|
| ProductNote |
THIS STANDARD ALSO REFERS TO ICH E3,ICH E6,ICH E8,ICH E9,MEDDEV 2.7.1
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NEN ISO 11249 : 2018 | Identical |
| BS ISO 11249:2018 | Identical |
| MEDDEV 2.12-1 : REV 8 : 2013 | GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| MEDDEV 2.12-2 : REV 2012 | POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
| ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices — Requirements and tests |
| ISO 15225:2016 | Medical devices Quality management Medical device nomenclature data structure |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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