ISO 23217:2024

Overview

ISO 23217:2024 - Injection systems for self‑administration by paediatric patients - Requirements and guidelines for design - is the first edition (2024) international standard that provides requirements and design guidance for injectable drug delivery systems intended to be used by paediatric patients who perform some or all use steps themselves. The standard addresses the full user lifecycle after the product is received, including transport, storage, preparation, operation, maintenance and disposal. It is applicable to a wide range of injection systems and can inform development of other paediatric drug delivery devices, while explicitly excluding technologies such as catheters (ISO 10555 series), infusion pumps (IEC 60601-2-24), and aerosol devices (ISO 20072).

Key topics and technical requirements

ISO 23217 focuses on human factors, risk management and design validation specific to the paediatric population. Major topics include:

• Design inputs and user profiles: defining intended use, paediatric age ranges, cognitive and motor abilities, and environmental contexts for self‑administration.
• Risk assessment: application of a risk‑based approach to identify hazards and estimate/mitigate risks associated with paediatric use.
• Usability engineering: integrating usability engineering (human factors) throughout design to reduce use errors and improve effectiveness, efficiency and user satisfaction.
• Use‑step considerations: guidance for each use step - transport, storage, preparation, operation, maintenance and disposal - that can introduce hazards or usability challenges for children and adolescents.
• Design verification and validation: requirements for verification activities and validation including usability evaluations (user studies) and clinical evaluation where appropriate.
• Accompanying documentation and IFU: considerations for instructions for use, packaging and other user interface elements tailored to paediatric users and caregivers.
• Normative references: aligns with ISO 13485 (quality management), ISO 14971 (risk management), and IEC 62366‑1 (usability engineering).

Applications and users

This standard is primarily intended for:

• Medical device manufacturers and design teams developing paediatric injection systems and auto‑injectors.
• Human factors engineers, risk managers and regulatory affairs professionals preparing design dossiers and usability data.
• Clinical evaluators and quality systems personnel conducting usability tests, risk analyses and design verification/validation.
• Health organizations and procurement teams assessing device suitability for paediatric self‑administration.

Related standards

• ISO 13485 - Medical devices - Quality management systems
• ISO 14971:2019 - Application of risk management to medical devices
• IEC 62366‑1 - Application of usability engineering to medical devices
• Exclusions: ISO 10555 (catheters), IEC 60601‑2‑24 (infusion pumps), ISO 20072 (aerosol devices)

Keywords: ISO 23217, paediatric injection systems, self-administration, drug delivery systems, usability engineering, risk management, design validation.