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14/30296035 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE 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Superseded date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 Risk assessment
5 Pilot clinical studies
6 Clinical validation investigation
Annex A (informative) - Formula for Power Calculation
Annex B (informative) - Pilot Clinical Investigation
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) - Single Use of Female Condom, data
        collection form
Annex G (informative) - Advert reaction report form (sample)
Annex H (informative) - Protocol for Evaluation of Returned
        Used Condoms
Bibliography

BS ISO 29943-2.

Committee
CH/157
DocumentType
Draft
Pages
47
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 25841:2017 Female condoms — Requirements and test methods
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices

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$39.22
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