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
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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
|
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