Overview
Some industries require proof that a material is safe and compliant, for food contact, medical use, drinking water, and more. Regulatory testing and documentation provide that proof so your part can be used where the rules are strict.
Food contact (FDA)
Support for FDA 21 CFR 177.2600 food-contact compliance for rubber articles, including documentation of compliant ingredients.
Medical biocompatibility, USP Class VI and ISO 10993
Two schemes come up on almost every medical print. USP Class VI is the United States Pharmacopeia's plastics classification, based on acute animal tests for systemic injection, intracutaneous reactivity, and implantation. ISO 10993 is the broader international series, Biological Evaluation of Medical Devices, and it is not a single test: Part 1 sets the evaluation within a risk-management process based on how and how long the device contacts the body, Part 5 covers cytotoxicity, Part 10 irritation and skin sensitization, Part 11 systemic toxicity, and Part 18 chemical characterization of the material.
Being clear about the division of work: the biological assays themselves are run by specialist biological testing laboratories. What CRC does is everything on the material and manufacturing side that those assays depend on, and the documentation your submission needs to connect the two.
- Selecting silicone and other grades that already carry USP Class VI or ISO 10993 test data from the raw-material supplier
- Formulating without the ingredients that create biocompatibility problems, and holding that formulation fixed
- Molding under controlled conditions, including post-cure where the grade requires it to drive off volatiles
- Physical and chemical property testing in our own ISO/IEC 17025:2017 accredited lab, which supports the chemical-characterization side of Part 18
- Lot traceability, material certifications, and change control, so the material tested is provably the material shipped
- Coordinating the biological testing itself with an accredited outside laboratory when your program needs it run on the finished part
A note worth having early: biocompatibility belongs to the finished device in its final form rather than to a compound in the abstract. A grade with existing data is where the work starts, and the testing that closes it is scoped against your device's contact type and duration.
Environmental & substance restrictions
- RoHS and REACH substance declarations
- Prop 65 considerations
- Material disclosure documentation