ASTM F3766-25

1.1 This guide provides general principles for generating a test report summary that presents results obtained using a standard for medical and surgical devices and materials, and it recommends best practices regarding both content and format of those test report summaries. While this guide is intended to describe the reporting of results from one standard at a time, the user is encouraged to use its principles when expanding or extending to apply to reports that summarize results from multiple standards.

1.2 This guide does not seek to address test report summaries for other applications outside of medical and surgical devices and materials, and it may not be appropriate for every medical or surgical device or material. The recommendations and principles are intended to be applicable to any medically related standard.

1.3 This guide is intended to help the user in generating test report summaries and to help consensus standards developers to write or revise Report sections of individual standards. It is intended to be applicable to any document other than a materials certificate where the user would be expected to provide a report. This guide is also not applicable to a material specification or a document that only describes general information without specifying any methods or results.

1.4 This guide is intended to supplement but not supersede any instructions provided in the Report section of an individual standard being applied, and if there is a conflict between the two documents, the individual standard shall take precedence. For example, if this guide fails to mention that a particular piece of information should be included in a test report, but the Report section of the standard requires that piece of information, or vice versa, the individual standard’s requirements shall be followed.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

4.1 This guide is intended to bring together ideas about best principles and practices from existing standards regarding the content and format of a test report summary for the purpose of presenting those ideas in one cohesive document.

4.2 Standards usually include a Report section that gives instructions on what to include in a report of results. For example, the Report section of a mechanical test method may give instructions on how to describe the testing components and apparatus, the testing parameters, failure modes, and quantitative results. These sections, however, have been developed by different subcommittees and working groups over time and may differ in their approach or content.

4.3 Test report summaries (which may or may not also be referred to as executive summaries) usually are a part of test reports, whether they are generated by device manufacturers themselves or external testing laboratories and describe the methods and results in a brief and summarized format. These test report summaries are often copied or adapted into regulatory submissions and are heavily relied upon for communication between stakeholders.

4.4 Clarity of communication in test report summaries is important not only for vendors and purchasers but also for regulatory purposes. A well-structured and well-formatted presentation of the results of pre-market testing is necessary to demonstrate how those results support the claims regarding conformance of a test unit to a test method, or more broadly, claims of product conformance to medical device regulations in various jurisdictions. Conversely, a poorly structured, poorly formatted presentation may slow the review process and result in clarifying questions and potentially the rejection of the conclusions for not being supported by the presented evidence.

4.5 Test report summaries, as a part of test reports, are also essential tools for teams sustaining a product on the market and teams developing next generation devices. With clear and sufficiently complete documentation of the materials, methods, and results, baseline comparisons to assess differences in performances can be made between predicate and current or proposed production of components or devices.