BS ISO 23217:2024 - Injection Systems for Self-Administration by Paediatric Patients

Standard Number: BS ISO 23217:2024

Pages: 48

Released: 2024-02-20

ISBN: 978 0 539 19616 0

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

Status: Standard

Overview

Introducing the BS ISO 23217:2024, a comprehensive standard that sets forth the requirements and guidelines for the design of injection systems specifically tailored for self-administration by paediatric patients. This standard is an essential resource for manufacturers, healthcare providers, and regulatory bodies involved in the development and implementation of paediatric injection systems.

Why Choose BS ISO 23217:2024?

Ensuring the safety and efficacy of medical devices for children is of paramount importance. The BS ISO 23217:2024 standard provides a robust framework to achieve this goal. Here are some key reasons why this standard is indispensable:

• Comprehensive Guidelines: The standard offers detailed guidelines on the design, testing, and validation of injection systems, ensuring they are safe and effective for paediatric use.
• Enhanced Safety: By adhering to the requirements of this standard, manufacturers can significantly reduce the risk of adverse events and complications associated with paediatric self-administration.
• Regulatory Compliance: Compliance with BS ISO 23217:2024 helps manufacturers meet regulatory requirements, facilitating market approval and acceptance.
• Improved User Experience: The standard emphasizes user-friendly design, making it easier for children and their caregivers to administer injections correctly and comfortably.

Key Features

The BS ISO 23217:2024 standard encompasses a wide range of features designed to ensure the highest quality and safety of paediatric injection systems:

• Design Requirements: Detailed specifications for the design of injection systems, including materials, dimensions, and ergonomics.
• Performance Criteria: Standards for the performance of injection systems, including accuracy, reliability, and durability.
• Safety Considerations: Guidelines for minimizing risks associated with self-administration, such as needle-stick injuries and dosing errors.
• Usability Testing: Requirements for usability testing to ensure that injection systems are easy to use and understand by paediatric patients and their caregivers.
• Labeling and Instructions: Standards for clear and comprehensive labeling and instructions to guide users in the correct use of the injection systems.

Who Should Use This Standard?

The BS ISO 23217:2024 standard is designed for a wide range of stakeholders involved in the development, regulation, and use of paediatric injection systems, including:

• Medical Device Manufacturers: Companies involved in the design and production of injection systems for paediatric use.
• Healthcare Providers: Medical professionals who prescribe and oversee the use of injection systems by paediatric patients.
• Regulatory Bodies: Organizations responsible for the approval and regulation of medical devices.
• Researchers and Academics: Individuals conducting research on paediatric medical devices and their use.

Benefits of Compliance

Adhering to the BS ISO 23217:2024 standard offers numerous benefits, including:

• Enhanced Patient Safety: By following the guidelines, manufacturers can ensure that their products are safe for paediatric patients, reducing the risk of adverse events.
• Increased Market Acceptance: Compliance with recognized standards can facilitate market approval and acceptance, making it easier to bring products to market.
• Improved Product Quality: The standard provides a framework for continuous improvement, helping manufacturers produce high-quality, reliable injection systems.
• Regulatory Compliance: Meeting the requirements of BS ISO 23217:2024 helps manufacturers comply with regulatory requirements, reducing the risk of non-compliance issues.

Conclusion

The BS ISO 23217:2024 standard is an invaluable resource for anyone involved in the design, production, and regulation of paediatric injection systems. By providing comprehensive guidelines and requirements, this standard helps ensure the safety, efficacy, and usability of these critical medical devices. Whether you are a manufacturer, healthcare provider, or regulatory body, adhering to BS ISO 23217:2024 is essential for delivering high-quality, safe, and effective injection systems for paediatric patients.

Invest in the BS ISO 23217:2024 standard today and take a significant step towards improving the safety and quality of paediatric healthcare.

BS ISO 23217:2024

This standard BS ISO 23217:2024 Injection systems for self-administration by paediatric patients. Requirements and guidelines for design is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters