Sterilization compatibility
The sterilisation method constrains the material. Autoclave is a temperature problem; gamma and e-beam are a chain-scission problem.
Published values
| Property | Value | Source |
|---|---|---|
| PI braided sheath | EO · gamma · e-beam · autoclave, single cycle advised | Principal brochure |
| PTFE liner | Autoclave · EO | Principal Company Profile |
| Biocompatibility — PEEK | ISO 10993-5 · ISO 10993-10 | Principal Company Profile |
| Biocompatibility — polyimide | ISO 10993-5 · ISO 10993-10 passed | Principal Company Profile |
“Autoclave, single cycle advised” means properties change under repeated sterilisation. For a reusable instrument that condition changes the design.
Property change after gamma or e-beam irradiation is not published by the principal. If dose and change rate are needed, we obtain them on request.
Biocompatibility testing is what the principal has passed at material level; it does not substitute for device approval. Testing per intended use is separate.
If one of these constrains your design
For items that need a number — tolerance, sterilisation, adhesion — tell us the requirement and we confirm it with the principal.