MARKET CHALLENGES

Hard To Bond Substrates Nylon, Coc/cop And Peba

Biocompatibility Testing

Medical-grade Standards Requirement

The Impact Of Sterilization Processes On Bonding Joint

 

PROSTECH’S SOLUTIONS

Furthermore, we do not promise to provide the best adhesive Adequate Adhesive Solution.  Some medical device adhesive applications require adhesives formulated to pass biocompatibility testing (not all medical devices), others require structural bonding of equipment.  It is more important to select the right adhesive rather than the best one.

In Medical Devices Manufacturing Industry, whether you are seeking a unique UV curable adhesive to bond a state-of-the-art oxygenator or a structural bond of an MRI housing we are here to help.

Bonding solutions for hard to bond substrates (Nylon, COC/COP and PEBA)

Biocompatibility adhesives

Medical-grade standards adhesives

Sterilization Resistant Adhesives

 

MEDICAL-GRADE STANDARDS

ISO 10993 biocompatibility standards (ISO 10993-5,-10,-11,-4,-6)

Depending on the application requiring an adhesive solution, many of our products also have passed ISO 10993 testing for skin sensitization and irritation as well.

ISO 13485 Medical Devices Quality Management

Ensuring that our products are made consistently and that they will conform to Medical Device Quality Management Standards.

USP Class VI Bio-compatibility of Materials

set by the US Pharma Convention (USP) with a focus on medications, healthcare technologies, food ingredients, and materials used in medical devices.

FDA Approval for Medical Devices

Since the user must submit his part for final testing and FDA certification, an adhesive’s qualification to ISO 10993 or USP Class VI is viewed as sufficient to allow a user to determine “probable” device acceptance.

WHY CHOOSE PROSTECH

Customer Sample Testing Support

Global Delivery

Medical-grade Adhesives Available For Shipping

Automate And Optimize Production Process

 

MEDICAL-GRADE ADHESIVE PRODUCTS

Detailed Application

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