14/30296035 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
Hardcopy , PDF
English
31-07-2017
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Superseded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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