⇒What is ISO 15197 In vitro diagnostic test systems?

ISO 15197 is an international standard that specifies requirements for systems used for self-monitoring of blood glucose (SMBG) in managing diabetes. The full title of the standard is “ISO 15197: In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
This standard provides guidelines and requirements for the accuracy and precision of blood glucose monitoring devices, ensuring that these devices meet specific criteria for performance and reliability. ISO 15197 covers aspects such as accuracy, user performance, and labeling information to enhance the quality and consistency of blood glucose measurements obtained by individuals with diabetes during self-testing. The goal of ISO 15197 is to establish a common framework for manufacturers to develop reliable blood glucose monitoring systems and for users to have confidence in the accuracy of the results obtained through self-monitoring. Compliance with this standard helps ensure that individuals with diabetes can effectively manage their condition with the support of accurate and reliable blood glucose monitoring devices

Benefits of ISO 15197 Standard:

→ Enhanced quality management

→ Global market acceptance

→ Regulatory compliance

→ Improved risk management

→ Increased customer confidence

→ Efficiency and cost savings

→ Cultivation of a continuous improvement culture

→ Emphasis on effective supply chain management

→ Emphasis on effective supply chain management

→ Competitive advantage

→ Facilitation of regulatory audits


⇒ISO 15197 Objectives:

ISO 15197 outlines several objectives aimed at establishing a standardized framework for blood glucose monitoring systems used for self-testing in managing diabetes mellitus.

The key objectives of ISO 15197 include:
Accuracy Requirements:
• Establishing strict criteria for the accuracy of blood glucose monitoring systems.
• Ensuring results obtained by users are reliable and consistent.
• Specifying acceptable levels of deviation between measured values and reference values.
User Performance:
• Defining requirements for usability and user-friendliness of devices.
• Enhancing overall performance of self-monitoring.
• Considering user instructions, ease of use, and user interface design.
Labeling and Information:
• Setting guidelines for information provided on the labeling of monitoring systems.
• Including clear and comprehensive instructions for use, warnings, and relevant information.
• Ensuring users understand and operate the device effectively.
Interference Testing:
• Addressing potential interferences affecting the accuracy of blood glucose measurements.
• Outlining procedures for testing and evaluating the impact of substances during self-testing.
• Establishing requirements for calibration procedures.
• Ensuring monitoring systems remain accurate over time.
• Providing guidelines for calibration intervals and methods.
Quality Management System:
• Encouraging manufacturers to implement a quality management system.
• Ensuring consistent production of reliable and accurate monitoring devices.
• Adhering to established quality assurance processes.
• Promoting traceability of measurements.
• Specifying requirements for reference measurement procedures and materials.
• Used in assessing the accuracy of blood glucose monitoring systems.