AAMI has published its first consensus report—a new kind of document developed to provide concise, prompt, and practical guidance on narrowly focused topics of high importance to the health technology community.
“The pace at which technology is evolving makes it difficult for traditional standards and technical information reports to keep up. AAMI members have voiced the need to have quicker guidance on issues where limited data exist, where there is variation in practice, or where there is confusion among stakeholders,” said Jen Padberg, AAMI senior vice president of standards program and policy. “To that end, the AAMI staff have, with consultation from members, developed a process by which much more rapid guidance can be provided in a new deliverable—an AAMI consensus report on emerging issues, or consensus report.”
AAMI CR500:2019, Basic Introduction to the IEC 60601 Series, is intended to clarify and to point out the importance of the IEC 60601 series of standards, as well as to provide guidance to understanding and to implementing the series. In particular, it explores how medical device manufacturers and their stakeholders—including FDA and other regulators—can best make use of the IEC 60601 series to ensure the safety of users/operators and patients.
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“The IEC 60601 series is a massive and complex body of work, and it can be a challenge to understand it. We developed AAMI CR500:2019 to be a guidebook for stakeholders to help them grasp the significance and value of this standard and—just as important—what it excludes,” Padberg said.
Consensus reports are intended to provide initial consensus guidance in response to an urgent/immediate need for guidance in the following instances:
While more robust data/information develops on emergent areas.
When variation in the development, implementation, or use of a product or process exists.
When existing standards or other documents require additional context or clarification.
A consensus report—or CR—is not subject to the same formal process as a standard, and while similar in nature to a technical information report (TIR), a CR is based on the collective knowledge and experience of a select group of stakeholders.
AAMI CR500:2019 was developed by a task group composed of representatives from manufacturing, testing laboratories, accreditation bodies and representatives from the U.S. Food and Drug Administration.
AAMI is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective healthcare technology.Back to HCB News