BS ISO 21151:2020 - In Vitro Diagnostic Medical Devices

The BS ISO 21151:2020 is a pivotal standard that sets the benchmark for in vitro diagnostic medical devices. Released on May 27, 2020, this comprehensive document spans 28 pages and is identified by the ISBN 978 0 539 01126 5. It is a crucial resource for professionals in the medical device industry, particularly those involved in the development, manufacturing, and quality assurance of diagnostic tools.

Overview

This standard outlines the requirements for international harmonisation protocols that establish metrological traceability of values assigned to calibrators and human samples. It is designed to ensure that diagnostic results are consistent, reliable, and comparable across different laboratories and geographical locations. By adhering to these protocols, manufacturers and laboratories can achieve a high level of accuracy and precision in their diagnostic measurements.

Key Features

• Standard Number: BS ISO 21151:2020
• Pages: 28
• Release Date: 2020-05-27
• ISBN: 978 0 539 01126 5
• Status: Standard

Importance of Metrological Traceability

Metrological traceability is a fundamental aspect of diagnostic testing. It ensures that the measurements obtained from diagnostic devices are traceable to recognized standards, providing confidence in the accuracy and reliability of test results. This is particularly important in the medical field, where diagnostic decisions can have significant implications for patient care and treatment outcomes.

The BS ISO 21151:2020 standard provides a framework for establishing metrological traceability, helping laboratories and manufacturers to align their processes with international best practices. This alignment not only enhances the credibility of diagnostic results but also facilitates regulatory compliance and market access.

Benefits of Compliance

Compliance with the BS ISO 21151:2020 standard offers numerous benefits to manufacturers, laboratories, and healthcare providers. These include:

• Enhanced Accuracy: By following the harmonisation protocols, diagnostic devices can deliver more accurate and reliable results, reducing the risk of errors and misdiagnoses.
• Global Consistency: The standard promotes consistency in diagnostic measurements across different regions and laboratories, enabling healthcare providers to make informed decisions based on comparable data.
• Regulatory Compliance: Adhering to the standard helps manufacturers and laboratories meet regulatory requirements, facilitating market access and reducing the risk of non-compliance penalties.
• Improved Patient Outcomes: Accurate and reliable diagnostic results contribute to better patient care, enabling timely and appropriate treatment interventions.

Who Should Use This Standard?

The BS ISO 21151:2020 standard is essential for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: Companies involved in the design and production of in vitro diagnostic devices can use this standard to ensure their products meet international quality and performance benchmarks.
• Laboratories: Clinical and research laboratories can implement the standard to enhance the accuracy and reliability of their diagnostic testing processes.
• Regulatory Bodies: Authorities responsible for overseeing the safety and efficacy of medical devices can reference the standard to establish compliance criteria and guidelines.
• Healthcare Providers: Hospitals and clinics can rely on the standard to ensure the diagnostic tools they use provide consistent and trustworthy results.

Conclusion

The BS ISO 21151:2020 standard is a vital resource for ensuring the quality and reliability of in vitro diagnostic medical devices. By establishing clear requirements for metrological traceability, it supports the development of diagnostic tools that deliver accurate and consistent results. Whether you are a manufacturer, laboratory, regulatory body, or healthcare provider, this standard provides the guidance needed to achieve excellence in diagnostic testing.

Embrace the BS ISO 21151:2020 standard to enhance the accuracy, reliability, and global consistency of your diagnostic processes, ultimately contributing to improved patient care and outcomes.

BS ISO 21151:2020

This standard BS ISO 21151:2020 In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand.

This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples.