Six months into using the revised ISO 10993‑1, many teams are running into the same uncomfortable realization: the standard tells us what to consider, but not always how literal to be when real‑world use patterns don’t fit neatly into tables. In this follow‑up webinar, we’ll explore a few deliberately unconventional but rational ways teams are thinking through biological risk estimation, reasonably foreseeable misuse, and contact duration for repeat‑use devices.
One example we’ll openly debate: if a patient is exposed to a device for one hour every year, are we really dealing with “long‑term” biological exposure, given that the standard states repeated use matters? If chemicals are fully clear long before the next use, should exposure be viewed cumulatively or episodically? And how much non‑exposure time is “enough” to justify that distinction?
Using real-world scenarios and audience polling, we’ll examine:
- Whether non-exposure periods can reasonably change how the duration of contact is framed
- How to apply qualitative or semi‑quantitative risk estimation when precise data doesn’t exist (and pretending otherwise adds little value)
- Ways to address reasonably foreseeable misuse without spiraling into infinite hypotheticals
This session is intentionally exploratory. We’ll share how different framing choices lead to different downstream expectations and how to document these decisions transparently, so they read as thoughtful judgment, not corner-cutting. Attendees should expect informed discussion and leave with new ways to think about the gray zones their teams are already navigating.
Speakers
Principal Toxicologist
Phil is a Principal Toxicologist in the Biological Safety Department at NAMSA. His experiences in the medical device field encompass toxicology, biological safety, preclinical study design, and extensive preparation of biological and toxicological risk assessments. Prior to his role in the Biological Safety Department, he was a Study Director overseeing special/custom preclinical functional studies, preclinical safety studies, and simulated-use chemistry studies.
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This is a free educational webinar.
