Clearer ISO 10993 rules and new data on silicone, TPU, PTFE, and PP‑R mean studios must treat “medical elastomers” as distinct chemistries, not interchangeable soft plastics. This article explains why BioFlex® is PP‑R, not TPU, and how to match each material to anatomy, wear time, and client history.
What the full article covers
Treat silicone, TPU, PTFE, and PP‑R jewelry as chemically distinct families, not interchangeable “soft plastics.”
BioFlex® and Bioplast are PP‑R random copolymers with ISO 10993‑6 implantation data behind them, not TPU or urethane-based elastomers.
New EN ISO 10993‑10:2023 and EN ISO 10993‑23:2021+A1:2025 change how irritation and sensitisation are evaluated for long-term skin-contact materials.
Orthodontic retainer data on TPU shows mild but measurable cytotoxicity, useful when deciding where soft retainers beat metal and where they don’t.
Studios should map jewelry material choice to anatomical location, wear time, and client history, not just flexibility or “medical grade” marketing language.
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First published on poliinternational.com. This is a summary of the original engineering article.
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