In the medical industry, material performance can be the difference between health and injury.
The most important aspect to consider concerns the compatibility of the material with the functionality the equipment requires.
When it comes to choosing materials for new medical equipment and devices, the team at Romar considers many factors, including biocompatibility, qualification, regulation and cost.
Restricted and Non-Restricted grades
Romar use two types of medical grade silicone in the development of medical devices for any application.
- Restricted grade silicone is suitable for implantation in the human body for up to 29 days (for example: tubing for a catheter).
- Non-restricted grade silicone is suitable for implant in the human body longer than 29 days.
Silicone Solutions for Medical Device Applications
Our broad portfolio of silicone elastomers for application in the healthcare industry has been tested against USPIV and ISO 10993 biocompatibility standards.
The distinctive properties of silicone elastomers – purity, clarity, strength, coupled with ease of processability – have resulted in their use in a broad range of medical device applications.
Our silicone materials exhibit exceptional stability over a wide range of temperatures, lending themselves to use in applications requiring repeated sterilisation.
Typical applications include (but are not limited to):
- dental/surgical devices
- diagnostic imaging
- fluid and drug delivery devices
- Septa/Stoppers laboratory accessories
- advanced wound care and scar management
- medical tubing
- wound drains and bulbs
- sterilisation mats
- pharmaceutical closures
- instrument grips
- dialysis O rings
- positioning devices
- seals/O rings/valves
- medical equipment keypad