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BSI PD ISO/TR 24484:2023

BSI PD ISO/TR 24484:2023

$102.76

Female condoms. Use of ISO 25841 and the quality management of female condoms

Published By Publication Date Number of Pages
BSI 2023 22
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PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Quality of design
4.1 General
4.2 Design input and design development
4.2.1 General
11 4.2.2 Barrier sheath
4.2.3 Product insertion feature and retention feature
12 4.2.4 Dressing materials
4.2.5 Lubricants
4.2.6 Biocompatibility
4.2.7 Control of bioburden
4.2.8 Packaging
13 4.3 Design verification
4.4 Design validation
4.4.1 Evaluation of barrier properties
4.4.2 Clinical (human use) investigations
4.4.3 Stability studies and shelf-life claim
14 4.5 Design output
4.5.1 General
4.5.2 Details of materials
4.5.3 Specifications of the female condoms
15 4.5.4 Supporting information
4.5.5 Regulatory compliance
4.6 Design transfer
4.7 Validation and change controls
5 Risk management
16 6 Quality in manufacture
18 7 Quality in testing
7.1 General
19 7.2 Test equipment
7.3 Sampling and testing:
7.4 Training and competence of personnel in testing
7.5 Review of results and reports:
20 8 Quality in procurement
9 Handling and disposal of used female condoms
21 Bibliography

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BSI PD ISO/TR 24484:2023
$102.76