ISO 10993 biocompatibility
Cytotoxicity (-5), sensitisation (-10) and irritation / sub-acute toxicity (-11) testing on the formulation. Implantation per -6 for series qualified as short-term implantable (
Industry · Medical
Platinum-cured silicone components for medical devices and hospital equipment
Tubes, gaskets, valves, connectors and moulded parts in silicone qualified to ISO 10993 + USP Class VI for infusion, dialysis, surgical drainage, diagnostic equipment and catheters. Production under ISO 13485 in ISO 8 cleanroom with MDR 2017/745 documentation file.
- ISO 10993 + USP VIBiocompatibility testing
- S17 · S10 · S12 · S30Medical platinum-cured series
- ISO 8 cleanroomsFrance + Italy
- ISO 13485 + 14971Medical QMS + risk management
What the sector demands
Verified biocompatibility. Repeated sterilisation. Documentary traceability under MDR 2017/745.
Silicone components in medical devices are in contact with tissue, blood, body fluids or medication during prolonged cycles — and must withstand repeated sterilisation (134 °C autoclave, ethylene oxide or gamma radiation) without degrading their properties. European regulation MDR 2017/745 and standard ISO 13485 set the management system; ISO 10993 and USP Class VI set the material testing. The whole chain, from raw material to packaging, travels under a technical file.
Four technical requirements
Biocompatibility · sterilisation · purity · traceability
Repeated sterilisation
Compatibility with saturated steam in 134 °C autoclave per ISO 17665, ethylene oxide (EtO) per ISO 11135 and 25-40 kGy gamma radiation per ISO 11137. Mechanical and dimensional properties are maintained through validated repeated cycles in the batch sheet.
Purity and transparency
Platinum catalysis with no volatile by-products (unlike peroxide curing). Mandatory post-cure in sealed stainless-steel oven to eliminate residual traces. Series S10, S12, S17 and S30 in translucent version for visual detection of obstructions; S17 also in radio-opaque version for X-ray detection.
MDR + ISO 13485 traceability
Every batch leaves with a unique number that travels from the base polymer's CoA to primary packaging. Compound mechanical data sheet, dimensional control drawings and certificate of conformity accompany every shipment. Documentary archive per MDR 2017/745 and ISO 14971 (risk management).
Manufacturing under control
ISO 8 cleanrooms dedicated to medical device production
Apt (France, 550 m² ISO 8) operates extrusion and moulding of medical silicone under ISO 13485 with extensometer, calibrated durometers and batch-level traceability. Top Tech Silicones (Italy, 1,500 m²) concentrates medical LSR injection with six dedicated presses and a primary packaging line in controlled flow. Both plants operate under the same Progress management system.
- ISO 13485 · medical QMS
- ISO 14971 · risk management
- ISO 14644-1 · cleanroom
- USP Class VI · testing
- MDR 2017/745 · file
Standards applicable to the medical sector
European and United States regulatory framework for medical devices and elastomer components in contact with tissue, blood or medication. Specific coverage of each series is verified case by case according to applied colorants and additives.
| Standard | Scope of application |
|---|---|
| ISO 13485 | Quality management system for medical devices · process certification |
| MDR 2017/745 | European Medical Device Regulation · technical file and traceability mandatory |
| ISO 10993-1 | General framework for biological evaluation of medical devices |
| ISO 10993-5 | In vitro cytotoxicity test of the formulation |
| ISO 10993-10 | Skin irritation and sensitisation test |
| ISO 10993-11 | Subacute and subchronic systemic toxicity test |
| ISO 10993-6 | Short-term local implantation test ( |
| USP Class VI | United States Pharmacopeia · biological compatibility test on medical elastomers |
| European Pharmacopoeia | Compliance of raw materials and additives for medical use |
| ISO 14971 | Risk management applied to medical devices |
| ISO 14644-1 | Cleanroom classes · ISO 8 cleanroom for critical production |
| ISO 17665 / 11135 / 11137 | Validation of sterilisation by steam, ethylene oxide and gamma radiation |
| REACH (CE 1907/2006) | Registration and restriction of chemical substances |
| RoHS (2015/863) | Restriction of hazardous substances in medical EEE |
- ISO 10993 and USP Class VI certifications are formulation certifications — they belong to the compound and are preserved provided no colourants or fillers that void them are introduced. ISO 13485 is a system certification — it belongs to the manufacturer. Final validation as a medical device is the responsibility of the medical product manufacturer, not the elastomer supplier.
- The Progress catalogue series with full ISO 10993 + USP VI coverage are S10, S12, S17 and S30. Only S17 (NuSil base) is qualified as short-term implantable (
Recommended Progress series
Platinum-cured catalogue for European medical devices
Four base series of the Progress catalogue cover virtually all medical applications: implantable, multipurpose, optically transparent and peristaltic pump. Selection is driven by biological contact (skin, mucosa, blood, short-term implantation), sterilisation method and geometry.
S17 · NuSil · Implantable medical
NuSil-based platinum-cured VMQ · Shore A 25-80 · range −60 / +200 °C · elongation 700-1200 %. Qualified short-term implantable (
S10 · Multipurpose food and medical platinum-cured
Platinum-cured VMQ · Shore A 40-80 · high tear strength (33-55 kN/m) · no volatile by-products. FDA + CE 1935 + ISO 10993 + USP VI where the formulation allows. For tubes, gaskets and moulded parts in contact with medication or food in the hospital environment.
S12 · High-certification transparent platinum-cured
Platinum-cured VMQ · Shore A 20-90 (widest range of the platinum catalogue) · range −60 / +200 °C (+300 °C transient). Translucent version for visual detection of obstruction in medication lines. FDA + CE 1935 + ISO 10993 + USP VI according to colorant.
S30 · Peristaltic pump platinum-cured
Platinum-cured VMQ · Shore A 50-65 · range −60 / +180 °C (+215 °C transient). Resistance to repeated deformation (controlled compression set) for peristaltic pumps in infusion, dialysis and medication delivery. Available only in extrusion. FDA + USP VI + ISO 10993.
Technical file per batch
Every medical component travels with its file · documentary archive per MDR
The base polymer supplier delivers each batch with its certificate of analysis (CoA) and declaration of compliance to ISO 10993 and USP Class VI. The banbury assigns a unique batch number maintained along the whole chain — formulation, calendering, extrusion or injection, post-cure in sealed stainless-steel oven, dimensional control, primary packaging and outer packaging.
Every shipment leaves with a certificate of conformity, compound mechanical data sheet, dimensional control drawings per ISO 3302-1 E1 (extrusion) or M2 (moulding) and a complete sterilisation history if the part requires it. The file is kept per MDR 2017/745 and ISO 14971, accessible for audits by European notified bodies.
Recommended products for the sector
Reference catalogue of the families most requested for medical devices: hospital equipment (autoclaves, MRI, CT, hyperbaric chambers), peristaltic pumps (infusion, dialysis, enteral nutrition), catheter connectors and valves, pacemaker components and drainage and suction systems.
| Product | Typical application in the sector | Datasheet |
|---|---|---|
| Medical silicone tubing | Connections for devices, hospital drainage and aspiration | View details |
| Peristaltic tubing | Infusion pumps, dialysis, enteral nutrition, medication administration | View details |
| Reinforced tubing | Surgical drainage, negative-pressure aspiration, breathing circuits | View details |
| Medical LSR injection | Catheter valves, connectors, infusion-pump components | View details |
| 2K bi-material overmoulding | Plastic-silicone overmoulding for pacemaker components and connectors | View details |
| Platinum O-rings | Sealing of diagnostic equipment, MRI, CT scanners, hyperbaric chambers | View details |
| Vulcanised seals | Hospital autoclave 134 °C, repeated sterilisation equipment | View details |
| Flat seals | Sealing of MRI equipment, CT scanners and hyperbaric chambers | View details |
- For each product, applicable series (S17 / S10 / S12 / S30), ISO 10993 test level, assigned group plant and tested-sample lead time are confirmed. For implantable components, only the S17 series (NuSil base) with short-term qualification (
Applicable group capabilities
How a medical component is manufactured in the Progress group
A medical component under ISO 13485?
Send us the type of biological contact (skin, mucosa, blood, short-term implantable), sterilisation method (autoclave, EtO, gamma), geometry and estimated series. We confirm the applicable series (S17, S10, S12 or S30), available ISO 10993 tests, group plant and sample lead time tested to USP Class VI. No purchase commitment.