Why biocompatibility data comes later
ISO 10993 data differs by material grade and sometimes by colour (colourant). Even for PEEK, natural and black have different files, and for parts that stay on the device, such as PET heat shrink, the device maker often runs its own tests. The safe order is to confirm at quotation whether data exists, and receive the actual documents before design freeze.
How to ask
- Give item, size and colour together. “PEEK tubing black, ID 1.3 mm, ISO 10993-5 · -10 data yes/no” is faster than “PEEK tubing biocomp”.
- Say whether you only need documents for registration and run tests yourself. If you run flexibility, sterilisation and biocompatibility tests in-house, only raw-material evidence is needed.
- If radiopaque fillers (BaSO₄ · Bi₂O₃ etc.) or colourants are used, confirm they are covered in the MSDS.
- Change control: put a notification procedure in the contract for changes in resin grade, plant or process after production starts.
Linstant produces in an ISO 13485:2016 certified plant (ISO class 7 · 8 cleanrooms). TDS · MSDS are sent with the quotation; biocompatibility data is confirmed per item and grade.