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Tubos médicos de silicona platino · conexiones para dispositivos sanitarios, drenaje y aspiración
Medical extrusion

Medical and pharmaceutical silicone tubing

Biocompatible silicone tubing manufactured in an ISO 8 cleanroom under an ISO 13485 management system. Platinum-cured formulations certified USP Class VI and ISO 10993 for medical devices, diagnostic equipment and pharmaceutical processes.

Contact usView technical specifications
ManufacturingISO 8 cleanroom · ISO 13485
CertificationsUSP VI · ISO 10993 · FDA
Curing systemPlatinum · no post-curing
Temperature–60 °C to +200 °C

Short-term implantable formulation (< 29 days) available under Series 17 with NUSIL grade. Consult specific requirements.

The product

Biocompatibility is demonstrated to USP Class VI or ISO 10993; batch traceability is a regulatory requirement.

Biocompatibility must be demonstrated to USP Class VI or ISO 10993 depending on the nature and duration of contact with the patient or pharmaceutical product. The manufacturing environment must be validated to prevent particulate contamination that would compromise the safety of the final device. And full batch traceability is a regulatory requirement, not an option.

Operario manipulando tubo de silicona en sala blanca
Control de tubos médicos en sala blanca
Medición de tubos de silicona en sala blanca
Inspección de tubos de silicona transparente
Tubo de silicona médica enrollado tras extrusión

Specifications

Dimensional tolerance
ISO 3302-1 · class E1 · lengths L2
Inner diameter
0.5 to 50 mm · wall thickness from 0.25 to 10 mm
Curing system
Platinum · no post-curing
Service temperature
–60 °C to +200 °C
Manufacturing environment
ISO 8 cleanroom · 550 m² · ISO 14644
Management system
ISO 9001:2015 · ISO 13485:2016
Biocompatibility
USP Class VI · ISO 10993
Food contact
FDA 21 CFR 177.2600 · CE 1935/2004
Restricted substances
REACH (1907/2006) · RoHS (2015/863)
Typologies

The type of medical tube is defined by its application and formulation

Type

  • 01Single layer
  • 02Striped (liseré)
  • 03Implantable
  • 04Peristaltic
Materials

Certified platinum formulations for medical use

Series 12 – Platinum-cure silicone with strong mechanical properties and versatility

Series 12 is a platinum-cured silicone compound processable by extrusion and moulding, recognised for its strong mechanical properties.

Shore A hardness20 – 90
Temperature range-60 °C / 200 °C
Peak temperature315 °C
Density (g/cm³)1.11 – 1.20
Tensile strength (MPa)6.0 – 9.0
Elongation at break (%)100 – 1000
Tear strength (kN/m)17.0 – 30.0
Curing systemPlatinum
Processing methodExtrusion and Moulding
Base colourNatural / Transparent
Available coloursRAL colours on request

Applications

  • Tubes (Øint 0.5–145 mm), profiles (cords, square, rectangular), moulded parts and industrial or medical applications.

Certifications and technical standards

  • FDA 21 CFR §177.2600
  • BfR IX and XV
  • CE 1935/2004
  • ISO 10993 (depending on formulation)
  • USP Class VI
  • RoHS compliant
  • REACH compliant
  • NF ISO 7619-1
  • NF ISO 37
  • NF ISO 34-1
  • NF ISO 2781
  • ISO 3302 (M2/E1/L2)

Series 10 – High-tear platinum-cure silicone for medical and food-grade applications

Series 10 is a platinum-catalysed silicone blend designed to deliver exceptionally high tear strength.

Shore A hardness40 – 80
Temperature range-60 °C / 200 °C
Density (g/cm³)1.12 – 1.24
Tensile strength (MPa)7.0 – 9.0
Elongation at break (%)320 – 760
Tear strength (kN/m)33.0 – 55.0
Catalysis typePlatinum
Processing methodExtrusion and moulding
Base colourNatural / Transparent
Available coloursRAL colours on request

Applications

  • Inflatable seals, tubes, profiles and moulded parts for industrial, medical and food-contact applications.

Certifications and technical standards

  • FDA 21 CFR §177.2600
  • BfR IX and XV
  • CE 1935/2004
  • ISO 10993 (depending on formulation)
  • USP Class VI
  • RoHS compliant
  • REACH compliant
  • NF ISO 7619-1
  • NF ISO 37
  • NF ISO 34-1
  • NF ISO 2781
  • ISO 3302 (M2/E1/L2)

Series 17 – Platinum-cure short-term implantable silicone (< 29 days)

Series 17 is a platinum-catalysed silicone blend, designed specifically for medical applications requiring short-term implantation (less than 29 days according to NUSIL data).

Shore A hardness25 – 80
Temperature range-60 °C / 200 °C
Density (g/cm³)1.11 – 1.20
Tensile strength (MPa)7.9 – 10.8
Elongation at break (%)700 – 1200
Tear strength (kN/m)33.5 – 46.7
Catalysis typePlatinum
Processing methodExtrusion and moulding
Base colourTranslucent

Applications

  • Tubing, tubing with radiopaque lines, profiles, moulded parts and O-rings for medical applications.

Certifications and technical standards

  • USP Class VI
  • ISO 10993 (depending on formulation)
  • RoHS compliant
  • REACH compliant

Series 30 – Platinum-cure silicone for peristaltic pumps and extrusion

Series 30 is a platinum-catalysed silicone blend, formulated exclusively for the extrusion process.

Shore A hardness50 – 65
Temperature range-60 °C / 180 °C
Density (g/cm³)1.14 – 1.17
Tensile strength (MPa)8.0 – 8.8
Elongation at break (%)400 – 500
Tear strength (kN/m)17.0 – 39.0
Catalysis typePlatinum
Processing methodExtrusion
Base colourTranslucent beige / Opaque beige
Available coloursRAL colours on request

Applications

  • Silicone tubing, peristaltic pumps, extruded profiles and industrial or medical applications.

Certifications and technical standards

  • FDA
  • USP Class VI
  • ISO 10993 (depending on formulation)
  • RoHS compliant
  • REACH compliant
  • NF ISO 7619-1
  • NF ISO 37
  • NF ISO 34-1
  • NF ISO 2781
  • ISO 3302 (E1/L2)
Producción aséptica en sala blanca ISO 8 · trazabilidad documental GMP
ISO 8 cleanroom extrusion

Medical tubing is manufactured entirely in the cleanroom

All medical tube production takes place in an ISO 8 cleanroom certified to ISO 14644-1, with 550 m² validated, positive pressure, HEPA filtration and continuous monitoring of particles, temperature and humidity. Staff access follows a gowning and airlock protocol, and critical process parameters are recorded for each batch.

Platinum curing — an addition reaction — produces no volatile by-products and requires no oven post-curing, the two typical steps with peroxide silicones that are avoided in the medical line. Each batch is supplied with a conformity certificate, process parameter records and full raw-material traceability for integration into the device's technical file.

Discover the ISO 8 cleanroom
Extrusión de tubo médico en sala blanca
Extrusión de tubo médico en sala blanca
Services and processes

Processes that support medical tube extrusion

Cut-to-length Service Cut-to-length Learn more → Seal vulcanising Service Seal vulcanising Learn more → Extrusion Process Extrusion Learn more → Design and tooling Process Design and tooling Learn more →
Catalogue

Related products to medical tubing

Peristaltic silicone tubing Product Peristaltic silicone tubing Learn more → Food-grade silicone tubing Product Food-grade silicone tubing Learn more → Custom silicone profiles Product Custom silicone profiles Learn more → LSR injection-moulded parts Product LSR injection-moulded parts Learn more →
Need a silicone tube for your medical device?

Tell us the device classification, the required dimensions, the nature and duration of patient contact and the necessary certifications. We confirm the suitable formulation and the documentation available for your technical file.

Email
info@prosilicones64.com
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