IronStats

Silicone.pro logo
ISO 13485 Registered
ITAR Registered
Facebook icon
LinkedIn icon
Twittericon
Google Plus icon
top of content

Medical Grade Silicone

What Is Non-Implantable Grade?

What Is Restricted Grade (short-term implant)?

What Is Unrestricted Grade (long-term implant)?

Albright specializes in manufacturing prototypes and low-production volumes of medical silicone components. We mold restricted and unrestricted medical grade liquid silicone rubber. In order to achieve the highest level of cleanliness, your medical grade silicone parts are molded in a Class 7 controlled environment room. Albright maintains an ISO 13485 certification to best serve our customers. To assure that all the parts you receive are fully crosslinked, all parts molded at Albright undergo a postbaking process to ensure a complete cure. It is critical that only certified medical grade silicone is used to mold your medical device components, typically medical grade silicone has a one year shelf life, for this reason it is extremely important that records are maintained for every batch.

Medical Parts

Medical Grade Silicone Molding

For medical applications the silicone must be medical grade. Medical grade silicone has special requirements that are different from industrial grade silicone. The major difference is that the silicone manufacturers have a special silicone grade that they manufacture for medical application. These silicones are tested for biocompatibility and meet the necessary FDA requirements. Any additives such as color must also be medical grade. Medical silicone applications are divided into two classes restricted and unrestricted. Normally, restricted is referred to as short term implantable and unrestricted is referred to as long term implantable. 

Types of medical grade silicone can be Room Temperature Vulcanization (RTV), High Temperature Vulcanization (HTV), Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). Hardness can range from gels to 80 Shore D.

Silicone manufacturers develop medical grade silicone compounds for a variety of specific medical applications. It is recommended to check with the intended silicone manufacturer before making the final silicone material decision. MatSilicone.com is a searchable database for medical grade liquid silicone materials, that is ideal for selecting the best material for your application.

Medical silicone parts require traceability to manufacturers lot number, material lot number, date of manufacture, processing parameters and other information. This is also required of any material additives such as color. Medical grade silicone must be postbaked to complete the cross linking and assure that there are no extrables.  Extractables can negatively affect the biocompatibility of the silicone material.