Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Planning an IUD trial - Good clinical practice
5 Ethics
6 Identification and description of the investigational
   device
7 Preliminary investigations and justification for the
   design of the clinical investigation
8 Objectives and hypotheses of the clinical investigation
9 Design of the clinical investigation
10 Adverse events, adverse device effects and non-medical
   complaints
11 Early termination or suspension of the clinical
   investigation
12 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

Abstract

Gives guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 157