BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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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