Short answer: what separates medical silicone from ordinary silicone is not the name of the material but grade plus validation — biocompatibility assessed under the ISO 10993 series and sterilization compatibility verified against the actual process, both backed by inspectable records. Scope note up front: this article, and our business, cover non-implant silicone components only (mask cushions, tubing, seals, connectors and other external-contact parts); implantable devices are outside our scope.
"Medical grade" is not a certificate — it is a set of requirements
The market often treats "medical-grade silicone" as a certificate; strictly speaking it is a composite concept: the compound must meet the relevant grade (e.g. USP Class VI, or an ISO 10993 assessment path), production must be traceable, and the finished part must pass tests designed around how and how long it contacts the body. In other words, the same compound used in different parts can reach different conclusions — because what matters is where the part touches and for how long.
How biocompatibility is assessed: the ISO 10993 series
| Part | What it evaluates | What it means for silicone |
|---|---|---|
| ISO 10993-5 | Cytotoxicity | A baseline test: the extract’s effect on cells |
| ISO 10993-10 | Irritation and sensitization | Critical for skin- or mucosa-contact parts (mask cushions, sleeves) |
| ISO 10993-11 | Systemic toxicity | Needed for parts with large contact area or long duration |
| ISO 10993-3 | Genotoxicity, carcinogenicity, reproductive toxicity | Included or waived based on contact duration and risk assessment |
The logic runs: classify the contact (surface / external communicating / implant) and its duration first, then select tests from the part list. Skipping that step and simply asking "which tests do we do" hands the assessment to the lab, which usually bounces it back for a defined intended use.
Choosing a sterilization method: the three mainstream routes
| Method | Typical conditions | Effect on silicone parts |
|---|---|---|
| Steam autoclave | 121 °C or 134 °C cycles | Silicone handles the heat easily; watch dimensional and elastic drift over repeated cycles — friendly to most general grades |
| Ethylene oxide (EO) | Low-temperature gas; aeration required to clear residues | Gentle on material but with a long aeration cycle; confirm how the compound sorbs EO |
| Gamma irradiation | Doses of 25–50 kGy | Irradiation crosslinks and scissions simultaneously; behaviour varies widely by grade, so before/after validation is mandatory |
Our scope: what we do and what we do not
Stating the boundary up front beats explaining it after the fact. What we do: moulding and secondary processing for non-implant silicone components — tubing, mask cushions, seals, connectors and overmoulded handles, all external-contact parts; sampling submissions and batch records can be arranged to your requirements. What we do not do: implantable medical devices; production carrying a cleanroom class requirement (we run platinum-cure capability, which is not the same thing); and plain plastic injection moulding.
FAQ
Do medical silicone parts always need platinum cure?
Not absolutely, but it is the mainstream choice. Platinum addition cure leaves no peroxide decomposition residues and starts from a lower extractables baseline, making the extraction and toxicity endpoints easier to clear; peroxide systems compensate through post-curing and fuller validation. Put the cure system in the spec as an explicit field rather than assuming a default.
Can you support ISO 13485 or device registration?
No — and this is a boundary we state plainly: we do not hold ISO 13485 certification and do not handle device registration. Our role is the moulding partner for non-implant silicone parts: we produce to your drawings and material spec, keep batch records and incoming-material certificates, and testing is performed by the third-party lab you designate. If your project requires a supplier with a certified quality system, a dedicated medical contract manufacturer is the right route.
Non-implant silicone components can be moulded to your drawings — see medical silicone parts for tubing, mask cushions and seals. Standard ranges start at 50 pieces with 5–7 working-day sampling. Put the contact site, contact duration and sterilization method in your enquiry and we will come back with material and process recommendations — contact us.
Frequently Asked Questions
Do you make medical silicone parts — and implantable ones?+
Non-implant parts yes: tubing, mask cushions, seals, connectors and overmoulded handles, built to drawing with batch records. Implantable devices are outside our scope; we do not hold ISO 13485 and do not handle device registration — stated plainly as our boundary.
Do medical silicone parts always need platinum cure?+
Not absolutely, but it is the mainstream choice. Platinum addition cure leaves no peroxide residues and clears extraction and toxicity endpoints more easily; peroxide systems compensate through post-curing and fuller validation. Put the cure system in the spec as an explicit field.
Does the sterilization method affect material choice?+
Yes. Steam (121/134 °C) is friendly to most general grades — watch dimensional and elastic drift over cycles; EO is gentle but needs long aeration; gamma irradiation crosslinks and scissions at once, varying widely by grade, so before/after validation is mandatory. Fix the sterilization method before choosing the compound.