14/30302761 DC : 0
NA
Status of Standard is Unknown
BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Planning an IUD trial - Good clinical practice
5 Ethics
6 Clinical Investigation Plan
7 Identification and description of the investigational device
8 Preliminary investigations and justification for the design of
the clinical investigation
9 Objectives and hypotheses of the clinical investigation
10 Design of the clinical investigation
11 Adverse events, adverse device effects and non-medical
complaints
12 Early termination or suspension of the clinical investigation
13 Publication policy
Annex A (informative) - Exclusion and inclusion criteria for IUD
trials
Annex B (informative) - Timing of insertion of IUD: When can an
IUD be inserted?
Bibliography
BS ISO 11249.
| Committee |
CH/157
|
| DocumentType |
Draft
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| 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 |
| ISO/TS 19218:2005 | Medical devices — Coding structure for adverse event type and cause |
| ISO/TR 16142:2006 | Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| MEDDEV 2.12-2 : REV 2012 | POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| 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 |
| ISO 15223:2000 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.
Important note : Users cannot be edited or removed once added to your Multi user PDF.