Silicone tubes with CE mark class IIa according to 93/42/EEC
Siltec is a specialist in the development, design and manufacture of extruded products and molded parts made of silicone. We have an extensive experience in medical technology and produce a large portfolio of silicone medical parts. This includes suction tubes, irrigation tubes, drainage tubes, which we offer as silicone tubes with CE mark class IIa according to 93/42/EEC.
The tubes act as suction, irrigation and drainage tubes for the transport (up to 29 days) of blood, body fluids and body-compatible fluids into and out of all human body orifices, with optional connection to suction and irrigation devices. This is possible both with and without connection to suction and flushing devices. Typical application areas of application include operating theaters, anesthesia, intensive care, and the treatment of medical emergencies.
We offer silicone tubes to distributors, purchasing associations and tradesmen. Furthermore, we cooperate with manufacturers of suction devices and rinsing devices, as well as manufacturers of finished drainage tube sets. They can rely on the CE mark (Class IIa according to 93/42/EEC) of the silicone tubing when applying for approval of their medical device.
The silicone hoses meet all biocompatibility requirements in the usual areas of application. They come with an instruction manual including detailed, validated preparation instructions. According to this manual, the tubes must be cleaned in an RDG and steam sterilized (134°C) before use. The excellent material resistance of silicone guarantees flexibility in the preparation. Any other common sterilization method such as heat, EO-gas or gamma sterilization is possible.
Would you like to discuss your needs or place an inquiry?
Benefits of our silicone tubes when used as suction tube, irrigation tube or drainage tube
We have numerous standard dimensions on stock. We can also produce special dimensions according to your needs.
Special quality features of Siltec‘s tubes
The silicone tubes offer these quality features:
With instruction manual, including validated instructions for preparation
Sterilizability (e.g., steam sterilization at 134°C)
Resistance to vapor and biological contamination
Flexibility and individuality in production
Depending on your needs, we can meet the following requirements:
Inner diameter from 1mm to 25mm, wall thickness from 0,5 to 4mm, product length certified up to 1 meter
Special sizes and tolerances available on request
Transparent / translucent
Additional or special label with customer logo
Single or double packaging in PE bags
We offer finished suction tubes, rinsing tubes or drainage tubes with CE mark class IIa (according to 93/42/EEC). We also configure and produce silicone tubes according to your requirements.
Our silicone tube with CE certificate for medical clinic operations
A medical silicone tube for the use as suction tube, rinsing tube or drainage tube:
Medical quality according to USP Class VI or ISO 10993 (as per agreement)
100% silicone rubber, biocompatible according to ISO 10993
Dimensions & specifications:
– Inner diameter min. 1,0mm / max. 25,0mm
– Wall thickness min. 0,5mm / max. 4,0mm
– Material qualities peroxide cured 40-80 shore A
– Platinum-catalyzed 60 Shore A
CE mark class Ila according to 93/42/EEC with manufacturer symbol Siltec
Custom-made: silicone tubes according to your requirements
We kindly offer our long-lasting experience in the production of medical silicone tubes to implement your requirements:
Variable lengths, tolerances, shore hardness, inner diameters and wall thicknesses
With X-ray contrast stripe (barium sulphate) for recognition in an X-ray image
Variable colors or with color stripe for easy identification of the tube
Quality according to various norms and certificates available, e.g.,:
– USP VI or ISO 10933, e.g., for cytotoxicity and skin irritation
– FDA §177.2600
– Further confirmations such as REACH, RoHs, latex-free, free from phthalates and free from materials of animal origin
Further options like the integration of heating, sensors, permanently connected sets, connections and labelling
SILPRESS® – tubes with fabric inserts for high pressures