BS EN ISO 11073-10424:2016

Overview

BS EN ISO 11073-10424:2016 is a critical standard within the realm of health informatics, specifically focusing on the communication protocols for personal health devices. This standard addresses the device specialization for sleep apnoea breathing therapy equipment (SABTE), facilitating interoperability and effective data exchange between devices and systems. The standard is part of a broader suite of ISO/IEEE 11073 standards aimed at improving the integration of medical devices into health information systems.

Key Requirements

The standard outlines specific requirements for the design and implementation of SABTE, ensuring that devices can communicate effectively with other health informatics systems. Key requirements include:

• Device Identification: Clear specifications for identifying and classifying SABTE devices to ensure consistent communication.
• Data Formats: Standardized data formats for transmitting patient information, device status, and therapy data.
• Communication Protocols: Defined protocols for data exchange, ensuring compatibility with existing health information systems.
• Security Measures: Guidelines for securing data transmission to protect patient privacy and comply with regulatory requirements.

Implementation Benefits

Adopting BS EN ISO 11073-10424:2016 offers several practical benefits for manufacturers and healthcare providers:

• Interoperability: Enhances the ability of SABTE devices to work seamlessly with other medical devices and health information systems, improving patient care.
• Data Accuracy: Standardized data formats and protocols reduce the risk of errors in data transmission, leading to more reliable patient monitoring.
• Regulatory Compliance: Aligning with this standard helps manufacturers meet regulatory requirements, facilitating market access and reducing the risk of non-compliance penalties.
• Patient Safety: Improved communication between devices can lead to better monitoring and management of sleep apnoea, enhancing patient outcomes.

Compliance Value

Compliance with BS EN ISO 11073-10424:2016 is essential for manufacturers of sleep apnoea breathing therapy equipment. It not only demonstrates a commitment to quality and safety but also provides a competitive advantage in the marketplace. By adhering to this standard, manufacturers can ensure that their devices are compatible with a wide range of health information systems, thus broadening their market reach.

Furthermore, compliance with this standard can facilitate smoother regulatory approvals, as it aligns with international best practices in medical device communication. This can significantly shorten the time to market for new devices and updates, allowing manufacturers to respond more swiftly to the evolving needs of healthcare providers and patients.

In conclusion, BS EN ISO 11073-10424:2016 is a vital standard for the effective communication of sleep apnoea breathing therapy equipment. By ensuring compliance, manufacturers can enhance interoperability, improve patient safety, and achieve regulatory success.