Standardization News

A new ASTM International standard will help medical device manufacturers collect sufficient data to demonstrate that they consistently clean medical devices to a safe and effective level.

The new standard (soon to be published as F3127, Guide for Validating Cleaning Lines for Medical Devices) is the result of a November 2011 symposium sponsored by ASTM on Cleaning Validation of Medical Devices. At the end of the symposium, organized by ASTM member Stephen Spiegelberg, Cambridge Polymer Group, there was consensus among attendees that a strong need existed for a guide that validates a standardized level of cleaning.

According to ASTM member Randall J. Thoma, principal consultant, VeeSquared Consulting Services, the new standard is relevant because, "society expects medical devices to improve quality of life. If there is a negative impact on quality of life because a device is not cleaned appropriately, then the patient is not helped."

While medical device manufacturers will be the main users of the new standard, it could also be helpful to regulatory agencies as a guide for expectations to which companies should be held. Laboratories and consultants could also use the standard as a way to support device manufacturers.

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CONTACT Technical Information: Randall J. Thoma, Ph.D., VeeSquared Consulting Services • Round Rock, Texas • tel +1.512.924.3832 | ASTM Staff: Kathleen Chalfin • tel +1.610.832.9717 | Upcoming Meeting: Nov. 15-18, 2016 • November Committee Week • Orlando, Fla.