BS EN ISO 11608-7:2017 - An Essential Standard for Injection Device Design

The BS EN ISO 11608-7:2017 standard serves as a critical reference point for the design and performance of pen-injectors used in the administration of therapeutic substances. As part of the broader EN ISO 11608 series, this standard outlines essential requirements for the safety, effectiveness, and usability of these innovative medical devices.

Key Features and Objectives

This standard was developed to ensure that pen-injectors, which are widely utilized in healthcare for the delivery of medications, meet stringent quality and safety requirements. It provides guidelines for manufacturers to produce reliable devices that enhance patient experience and clinical outcomes.

• Comprehensive Guidelines: The document addresses various aspects of pen-injector design, including usability, accurate dosage delivery, and patient safety.
• Risk Management: Implementing a robust risk management strategy in the design and production phases is emphasized, ensuring potential hazards are identified and mitigated effectively.
• Usability Requirements: To enhance user interaction, the standard stipulates usability testing procedures that assess the device's ease of use for patients and healthcare providers alike.
• Quality Control: The standard mandates rigorous testing protocols to validate the reliability and performance of the injection devices under real-world conditions.

Why Choose BS EN ISO 11608-7:2017?

By adhering to BS EN ISO 11608-7:2017, manufacturers position themselves as leaders in the healthcare technology sector by committing to high-quality standards. Compliance with this standard not only fosters trust among users but also ensures organizations meet regulatory requirements across the globe.

Accessibility and Formats

The standard is available in both PDF and hardcopy formats, offering flexibility to organizations in their preferences for accessing critical compliance documentation. Priced at £220.00, investing in this standard is a critical step towards enhancing product quality and operational safety.

Conclusion

BS EN ISO 11608-7:2017 is an indispensable guide for organizations involved in the design and manufacturing of pen-injectors. By following its guidelines, stakeholders can assure the delivery of safe and effective healthcare solutions, ultimately promoting better health outcomes for patients.