Medical hygiene and resilience due to silicone

30th October 2023
Harry Fowle

ODU has developed silicone-moulded system solutions to meet the hygienic and mechanical requirements of medical devices.

The devices feature non-stick surfaces and their properties are convincing as they are easy to clean, steam sterilisable, flexible, insensitive to extreme temperatures and tested according to DIN EN ISO 10993-5. This makes them a hygienic and robust solution for insert in everyday medical use.

In order to meet medical requirements, we offer individual silicone-moulded system solutions consisting of connectors, overmoulding as well as cables as qualified cable assemblies while optionally providing laser markings in accordance with Unique Device Identification (UDI).

ODU silicone overmouldings for the medical industry

The company has evolved over the years to become a specialist in custom overmoulding. The tools developed and manufactured at ODU for straight or angled designs are designed (depending on the application) for samples, small series or large series production.

Since applications in the medical sector have to meet special hygienic and mechanical requirements, the contact specialist's silicone overmoulding connects the ODU connector to the certified silicone cable and combines the best feel with hygiene and resistance. The silicone overmouldings are easy to clean, flexible, insensitive to extreme temperatures and cannot be peeled off or detached even after the required autoclaving cycles (steam sterilisation at up to 134 °C and 3,040 mbar). The biocompatibility with regard to cytotoxicity testing (outgassing) according to DIN EN ISO 10993-5 is confirmed by an external testing laboratory.

The complex process of silicone overmoulding enables an absolute tight yet flexible connection of the silicone cables to the connector (kink protection according to DIN EN ISO 61010-031 as well as increased strain relief) and is adapted to the specific material properties of the silicone cable.

Any quantity and length

The ODU silicone portfolio includes numerous silicone cables from qualified suppliers and includes the required certifications as well as further inspections regarding surface condition, adhesion and cleaning so that no further certification procedures are required on the customer side. Through appropriate partnerships, ODU can always offer the cable assemblies in consistent quality (for example, adhesion to cable jacket) and already in small quantities. The cable assembly is available in any length.

Advantages of the ODU silicone overmoulded system solution

Customers benefit from the following advantages with the ODU silicone overmoulded system solution:

  • Certified quality of the silicone-moulded complete solution (biocompatibility with regard to the cytotoxicity test (outgassing) according to DIN EN ISO 10993-5 as well as kink protection according to DIN EN ISO 61010-031)
  • Pleasant, tack-free feel of the silicone overmould (even for patterns or small batches) without stick-Slip-Effect
  • Fast availability
  • Fair pricing (incl. cost reduction vs. individual acquisition)
  • Length neutrality
  • Reduced effort as no certification is required, the supply chain is limited to one contact and only one part number needs to be managed by the customer

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