BS EN ISO 20916:2024 - In vitro Diagnostic Medical Devices

Clinical Performance Studies Using Specimens from Human Subjects. Good Study Practice

Standard Number: BS EN ISO 20916:2024

Pages: 76

Released: 2024-03-07

ISBN: 978 0 539 16970 6

Status: Standard

In the rapidly evolving field of medical diagnostics, ensuring the accuracy, reliability, and safety of in vitro diagnostic (IVD) medical devices is paramount. The BS EN ISO 20916:2024 standard is your comprehensive guide to conducting clinical performance studies using specimens from human subjects, adhering to the highest standards of good study practice.

Why Choose BS EN ISO 20916:2024?

This standard is meticulously crafted to provide a robust framework for the clinical performance evaluation of IVD medical devices. Whether you are a manufacturer, researcher, or healthcare professional, this document is an indispensable resource for ensuring that your clinical studies are conducted with the utmost integrity and scientific rigor.

Key Features and Benefits:

• Comprehensive Guidance: With 76 pages of detailed instructions, this standard covers every aspect of clinical performance studies, from study design to data analysis.
• Up-to-Date Information: Released on March 7, 2024, this standard reflects the latest advancements and regulatory requirements in the field of IVD medical devices.
• Global Relevance: As an ISO standard, it is recognized and respected worldwide, facilitating international collaboration and compliance.
• Enhanced Reliability: By following the guidelines in this standard, you can ensure that your clinical performance studies yield reliable and reproducible results.
• Ethical Considerations: The standard emphasizes the importance of ethical practices, ensuring the protection and respect of human subjects involved in clinical studies.

Who Should Use This Standard?

This standard is essential for a wide range of professionals involved in the development, evaluation, and regulation of IVD medical devices, including:

• Medical Device Manufacturers
• Clinical Researchers
• Regulatory Affairs Specialists
• Quality Assurance Professionals
• Healthcare Providers

What’s Inside?

The BS EN ISO 20916:2024 standard is divided into several key sections, each providing detailed guidance on different aspects of clinical performance studies:

• Introduction: An overview of the purpose and scope of the standard.
• Study Design: Guidelines on designing robust and scientifically sound clinical performance studies.
• Ethical Considerations: Best practices for ensuring the ethical treatment of human subjects.
• Data Collection and Management: Instructions on collecting, managing, and analyzing data to ensure accuracy and reliability.
• Reporting Results: Guidance on how to report study findings in a clear and transparent manner.
• Quality Assurance: Best practices for maintaining high standards of quality throughout the study.

Stay Ahead with the Latest Standards

In the competitive and highly regulated field of medical diagnostics, staying up-to-date with the latest standards is crucial. The BS EN ISO 20916:2024 standard not only helps you meet regulatory requirements but also enhances the credibility and reliability of your clinical performance studies.

Invest in Quality and Compliance

By adhering to the guidelines set forth in this standard, you are investing in the quality and compliance of your IVD medical devices. This not only helps you gain regulatory approval but also builds trust with healthcare providers and patients, ultimately contributing to better health outcomes.

Order Your Copy Today

Don’t miss out on this essential resource for conducting clinical performance studies with the highest standards of good study practice. Order your copy of the BS EN ISO 20916:2024 standard today and take the first step towards ensuring the accuracy, reliability, and safety of your IVD medical devices.

ISBN: 978 0 539 16970 6

Released: 2024-03-07

Pages: 76

Status: Standard

Ensure your clinical performance studies are conducted with the highest level of integrity and scientific rigor. The BS EN ISO 20916:2024 standard is your key to achieving excellence in the field of in vitro diagnostic medical devices.

BS EN ISO 20916:2024

This standard BS EN ISO 20916:2024 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results, — define the responsibilities of the sponsor and principal investigator, — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications[1][12][13]. NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.