14/30296392 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
Hardcopy , PDF
31-07-2017
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Pilot clinical studies
5 Clinical validation investigation
Annex A (informative) - Formula for power calculation
Annex B (informative) - Pilot clinical investigation
(sample outline)
Annex C (informative) - Time and Events Schedule for
individual study subject (sample)
Annex D (informative) - Study Entry, data collection form
Annex E (informative) - Mid-study, data collection form
Annex F (informative) - Individual condom use, data
collection form
Annex G (informative) - Adverse reaction report form (sample)
Annex H (informative) - Protocol for Evaluation of Returned
Used Condoms
Bibliography
BS ISO 29943-1.
| Committee |
CH/157
|
| DocumentType |
Draft
|
| Pages |
49
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 16037:2002 | Rubber condoms for clinical trials — Measurement of physical properties |
| ISO 23409:2011 | Male condoms Requirements and test methods for condoms made from synthetic materials |
| ISO 4074:2015 | Natural rubber latex male condoms Requirements and test methods |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
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