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14/30296392 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
Available format(s)

Hardcopy , PDF

Superseded date

31-07-2017

Language(s)

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Superseded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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