CKMOLD Blog

USP Plastic Class VI and ISO 10993 are not two levels of the same approval. USP <88> describes defined in-vivo biological-reactivity tests for plastics and assigns test classifications under specified extraction and exposure conditions. ISO 10993-1:2025 is a risk-management framework for planning the biological evaluation of a medical device according

Selecting a TPE for a medical-device component is a device risk-management task, not a search for a generic “medical-grade” plastic. Start with the component’s body-contact category, duration, function, cleaning or sterilization exposure and regulatory pathway. Then select and validate an exact supplier grade. What makes a TPE candidate suitable for

A premium soft-touch surface comes from a controlled material–geometry–tool–process system, not from choosing a low Shore hardness alone. Start with the user’s grip, wear and cleaning conditions; then match a TPE grade to the rigid substrate and validate the appearance and bond on production-representative parts. Translate “premium feel” into measurable

No plastic is environmentally preferable in every application. Compare candidates using the same functional unit—such as one accepted part over its required life—and verify the real collection, sorting and reprocessing route. A recyclable polymer used in an incompatible multi-material assembly may perform worse at end of life than its resin

PP, TPE and silicone cannot be ranked with one “heat-safe and food-safe” score. PP may be efficient for rigid containers and hinges, TPE for flexible seals and overmolds, and silicone for flexible parts exposed to higher temperatures—but the exact grade, food type, time/temperature and cleaning cycle determine suitability. Compare the

TPE, silicone and natural rubber can all be appropriate for baby products, but none is automatically “safest.” The correct choice depends on the product’s age grading, whether it is a toy or child-care article, mouthing or food contact, cleaning temperature, allergy considerations, mechanical hazards and the exact formulation. For rigid

There is no universally “safest plastic.” A material is appropriate only when its exact formulation, intended contact, temperature, service life, manufacturing process and applicable market rules are considered together. Resin identification codes describe polymer categories for sorting; they are not toxicity rankings. Start with the exposure, not the resin name

TPE, TPU and silicone are material families, not safety ratings. For a consumer product, compare exact grades under the same skin/food contact, temperature, chemical, mechanical and market requirements. Safety documentation and functional durability must both be verified. First separate chemistry from product claims TPE is an umbrella term that includes