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Jun 06, 2025
A proposed ASTM International standard will provide general principles for generating test report summaries from standards for medical and surgical materials and devices. The proposed standard (WK92947) will also recommend best practices regarding both the content and form of these summaries.
ASTM’s medical and surgical materials and devices committee (F04) is developing the proposed standard.
“This proposed guide will help manufacturers and laboratories looking to generate clearly written and structured test reports,” says ASTM member Jove Graham, associate professor, Center for Pharmacy Innovation and Outcomes, Geisinger Health. “It will help those who are writing new standards to make their report sections more consistent, and it will help the users of test report summaries.”
Graham notes that clarity of communication in test reports is important for vendors, purchasers, and regulators of medical and surgical materials and devices.
“A well-structured and well-formatted presentation of the results of premarket 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,” says Graham.
ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.
July / August 2025
