ISO/IEEE 11073-10422:2017

Overview

ISO/IEEE 11073-10422:2017 is a vital standard within the realm of health informatics, specifically focusing on the communication protocols for personal health devices. This standard is particularly relevant for urine analysers, providing a framework for device specialization that enhances interoperability and data exchange between devices and health information systems.

Key Requirements

The standard outlines essential requirements for the design and implementation of urine analysers, ensuring they can effectively communicate with other health devices and systems. Key aspects include:

• Device Communication: Establishes protocols for data transfer, ensuring accurate and timely communication of health metrics.
• Data Formats: Specifies standard data formats for urine analysis results, facilitating compatibility across various health informatics systems.
• Interoperability: Promotes seamless integration with electronic health records (EHR) and other health management systems.
• Device Specialization: Defines the unique characteristics and functionalities of urine analysers, allowing for tailored applications in clinical settings.

Implementation Benefits

Implementing ISO/IEEE 11073-10422:2017 offers numerous benefits for healthcare providers and device manufacturers:

• Enhanced Data Accuracy: By adhering to standardized communication protocols, urine analysers can provide more reliable data, reducing the risk of errors in patient management.
• Improved Patient Care: Quick and accurate data transmission allows healthcare professionals to make informed decisions promptly, enhancing patient outcomes.
• Cost Efficiency: Standardization reduces the need for custom integration solutions, lowering development and operational costs for manufacturers.
• Regulatory Compliance: Aligning with this standard helps manufacturers meet regulatory requirements, facilitating market entry and acceptance.

Compliance Value

Compliance with ISO/IEEE 11073-10422:2017 is crucial for manufacturers and healthcare providers aiming to ensure their devices meet industry standards. The standard provides a clear framework that supports:

• Regulatory Approval: Adhering to this standard can streamline the approval process with regulatory bodies, ensuring devices are compliant with national and international regulations.
• Market Competitiveness: Manufacturers that comply with established standards can enhance their market position, demonstrating commitment to quality and interoperability.
• Patient Safety: By ensuring devices communicate effectively, the standard helps mitigate risks associated with miscommunication or data loss, ultimately safeguarding patient health.

In conclusion, ISO/IEEE 11073-10422:2017 is a critical standard that facilitates effective communication between urine analysers and health information systems. Its implementation not only enhances data accuracy and patient care but also ensures compliance with regulatory requirements, providing significant value to manufacturers and healthcare providers alike.