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BSI 23/30471829 DC:2023 Edition

BSI 23/30471829 DC:2023 Edition

$13.70

BS ISO 23217.2. Injection systems for self-administration by paediatric patients. Guidelines for design

Published By Publication Date Number of Pages
BSI 2023 49
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PDF Catalog

PDF Pages PDF Title
1 30471829.PDF
3 ISO_DIS 23217.2 ed.1 – id.74899 Enquiry.2 PDF (en).pdf
6 Foreword
7 Introduction
9 1 Scope
10 2 Normative references
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
21 4.4.3 Considerations for accompanying documentation
5 Development of the design
22 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)
23 6.3.3 Clinical evaluation
25 Annex€A (informative) Additional considerations for the “paediatric population”
47 Bibliography

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BSI 23/30471829 DC
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