Approvals and documentation
Every statement on this page is backed by a test report or a declaration of conformity. What we do not hold is listed at the end — plainly, and without detours.
USP Class VI, chapters <87> and <88>
Tested for biological reactivity in vitro and in vivo. These are the two materials we use in medical technology.
| Material | Documentation | Particular feature |
|---|---|---|
| FPM-PTFE-8 | USP Class VI <87>, <88> | PTFE membrane on the sealing lip, low friction |
| FPM-PTFE-19 (F19) | USP Class VI <87>, <88> | FEP version, suitable for gamma sterilization |
Both materials are CIP- and SIP-capable and temperature-resistant to 230 °C. Which design fits your dimensions is something we settle in the inquiry.
FDA 21 CFR 177.2600, in full
In full means paragraphs (a) to (f), including the extraction tests in aqueous medium and in n-hexane. The extraction results are on file.
| Material | FDA 21 CFR 177.2600 | EU 1935/2004 and GMP 2023/2006 | metal-detectable |
|---|---|---|---|
| FPM-PTFE-9 | in full | ja | no |
| FPM-PTFE-29 | in full | ja | ja |
| FPM-B9 | in full | ja | ja |
| EPDM-3 | in full | ja | no |
| HNBR-5 | in full | ja | no |
| VMQ-6 | in full | ja | no |
What applies to every one of our materials
These records do not depend on an individual grade; they apply across our entire materials range.
California Proposition 65
No warning label required.
Free from
Free from ADI, free from TSE/BSE and free from BPA to EU 2024/3190.
Chemicals legislation
RoHS II and III, REACH, PAH, POP and GADSL.
Conflict minerals
Conflict Minerals Reporting Template (CMRT) on request.
Declaration of Conformity
Not a blanket document issued at some point in the past, but a declaration that belongs to your order.
In English
The declaration is written in English and can be used without translation.
Clearly assigned
With our order number and your purchase order number — the declaration can be matched to the delivery, even years later.
Valid for 12 months
After that we issue it afresh for the follow-up order, reflecting the state of documentation at that time.
We will send you a sample document on request.
What we are not certified to
These three are asked for frequently in North America. We do not hold them, and we do not claim to.
- ISO 10993 — Biological evaluation of medical devices. Not held for our materials; for material testing we cite USP Class VI.
- 3-A Sanitary Standards — Not held. For food contact we cite FDA 21 CFR 177.2600 and EU 1935/2004.
- NSF — Not held.
For the materials NBR-1, FPM-2, FPM-Per-7, HNBR-C5, HNBR-CP5, FPM-C2 and PTFE-K there is neither FDA nor USP documentation. If your application calls for one of them, say so in your inquiry — we will then look for a grade for which the documentation exists.