BS ISO 23217:2024

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Injection systems for self-administration by paediatric patients. Requirements and guidelines for design

Published By	Publication Date	Number of Pages
BSI	2024	48

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Categories: 11.040.25 - Syringes, needles and catheters, BSI

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Description

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PDF Pages	PDF Title
2	undefined
6	Foreword
7	Introduction
9	1 Scope 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 Considerations for the determination of requirements for the design of medical devices specific to paediatric users 4.3.1 Considerations in relation to risk (risk-based approach to design) 4.3.2 Considerations in relation to human factors
20	4.3.3 Considerations for accompanying documentation 5 Development of the design
21	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)
22	6.3.3 Clinical evaluation
24	Annex A (informative) Additional considerations for the “paediatric population”
45	Bibliography

Additional information

Status	Definitive
Pages	48
Publication Date	2024-02-20
ISBN	978 0 539 19616 0
Standard Number	BS ISO 23217:2024
Title	Injection systems for self-administration by paediatric patients. Requirements and guidelines for design
Identical National Standard Of	ISO 23217 ed.1
Descriptors	Medical instruments, Injection instruments
Publisher	BSI
Committee	CH/84
ICS Codes	11.040.25 - Syringes, needles and catheters

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BS ISO 23217:2024

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