BS EN ISO 11608-4:2007 - Essential Standard for Injection Devices

BS EN ISO 11608-4:2007 is a critical standard within the healthcare technology sector, addressing design and safety considerations for injection devices. This document is essential for manufacturers, regulators, and healthcare professionals involved in the design and utilization of such devices, ensuring compliance with the latest international performance criteria.

Overview

Adopted on September 28, 2007, this standard is identical to ISO 11608-4:2006, thus harmonizing with global regulations. The guide provides comprehensive specifications for the symbiotic relationship between technology and healthcare, focusing specifically on the safety, efficacy, and usability of injection devices. Compliance with BS EN ISO 11608-4:2007 is vital for organizations seeking to enhance patient safety and improve health outcomes.

Key Features

• Structured Guidelines: The standard outlines a systematic framework for the design, evaluation, and validation of injection devices, emphasizing critical aspects such as usability, risk analysis, and user training.
• Consistency in Quality: By adhering to this standard, manufacturers ensure that their devices meet consistent quality benchmarks, fostering trust and reliability among healthcare providers and patients.
• Regulatory Compliance: Complying with BS EN ISO 11608-4:2007 assists organizations in meeting regulatory requirements, thus streamlining market entry for new products.

Who Should Use This Standard?

This standard is invaluable for:

• Developers and manufacturers of injection devices including syringes, auto-injectors, and infusion devices.
• Regulatory authorities ensuring product compliance with international standards.
• Healthcare institutions aiming to bolster the safety and effectiveness of their medical devices.
• Quality assurance and control teams involved in the evaluation of medical technologies.

Conclusion

BS EN ISO 11608-4:2007 serves as an essential resource for organizations committed to excellence in the development and implementation of injection devices within healthcare. By integrating its guidelines into their practices, stakeholders can enhance patient care, mitigate risks, and maintain compliance with international norms. For purchase, this document is available in both PDF and hardcopy formats for your convenience. Empower your organization with the assurance that comes from adherence to recognized standards.