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BSI 22/30445135 DC:2022 Edition

BSI 22/30445135 DC:2022 Edition

$13.70

BS ISO 23217. Injection systems intended for self-administration by paediatric patients. Guidance for design

Published By Publication Date Number of Pages
BSI 2022 46
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PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
13 4 Considerations for design inputs
4.1 General
4.2 Risk assessment and usability engineering
4.2.1 Risk assessment
4.2.2 Usability engineering
4.3 Determination of the intended demographic population
14 4.4 Considerations for the determination of requirements for the design of medical devices specific to paediatric users
4.4.1 Considerations in relation to risk (risk-based approach to design)
4.4.2 Considerations in relation to human factors
15 4.4.3 Considerations in relation to design attributes
19 4.4.4 Considerations for accompanying documentation
5 Development of the design specification
20 6 Design verification and validation
6.1 General
6.2 Design verification
6.3 Design validation
6.3.1 General
6.3.2 Usability evaluations (also known as usability tests or user studies)
21 6.3.3 Clinical evaluation
23 Annex€A (informative) Additional considerations for the “paediatric population”
44 Bibliography

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BSI 22/30445135 DC
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