Solvay offers the industry’s broadest selection of high-performance thermoplastics for implantable and non-implantable medical devices. We also provide global technical and regulatory support.

With over 25 years of experience as a leading materials supplier to the healthcare industry, Solvay provides the commitment, experience and innovation that medical device manufacturers need from their partners. 

Based on biocompatibility testing as defined by ISO 10993:1, our healthcare products demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity. Compatibility with various sterilization methods is product specific and includes gamma radiation, ethylene oxide, vaporized hydrogen peroxide and steam. 

These categories represent areas where Solvay healthcare plastics are commonly used and do not imply fitness for use.

Healthcare

New AM Grades

Solvay Launches Additive Manufacturing Grades for Healthcare Industry

High-Performance Medical Grade Plastics

Performance requirements for medical equipment, cases and trays, surgical instrumentation and other non-implantable medical devices vary widely, but they share a common need for the high performance that Solvay’s medical grade plastics provide. These materials are suitable for limited exposure applications that are in contact with bodily fluids or tissue for less than 24 hours.

  • Reusable and single-use devices
  • Compatible with cleaning agents and disinfectants
  • Transparent, opaque and gamma-stabilized colors
  • FDA Master Access File (MAF) supported color palettes
  • Silicon overmolding for ergonomic designs
  • Enable metal-to-plastic conversion

Typical Applications

  Orthopedics Sterilization Cases &
Trays
Reusable Medical & Dental Devices Single-Use Surgical Instruments Hemodialysis Membranes
Radel® PPSU √       √          
Veradel® HC PESU    
Udel® PSU  
Ixef® PARA    
AvaSpire® PAEK      
KetaSpire® PEEK      

Solviva® Biomaterials for Implantable Devices

Solviva® Biomaterials are offered for use in implantable medical devices, specifically those that are in contact with bodily fluids or tissue for more than 24 hours. Our dedicated production facility in Georgia, USA, is ISO 13485 compliant and operates under the relevant aspects of current Good Manufacturing Practices. All materials are tested in accredited laboratories that have ISO 9001 certification and are ISO 17025 accredited.

  • Over 100 510(k) clearances and numerous CE marks
  • Meets ASTM F2026-2016 (PEEK only) and YY/T 0660-2008
  • Streamlined contract negotiations
  • Ship directly to processors
  • Process validation
  • Product traceability
  • Brands available: Zeniva® PEEK, Veriva® PPSU, Eviva® PSU
Biocompatibility Testing

As a proactive partner with healthcare OEM’s for more than 25 years, we understand the stringent industry requirements designed to ensure biological safety and protect the public’s health, and we offer comprehensive regulatory support.

  • Global standardization based on ISO 10993 methods
  • Robust data dossiers, including FDA Master Access Files (MAFs) for materials used in long-term implantable and limited body contact applications
  • Region-specific regulatory specialists can assist and support your submissions, petitions, and certificate requests

 

 Test Method Zeniva®
PEEK
Veriva® PPSU 
Eviva® PSU
AvaSpire® PAEK 
KetaSpire® PEEK
Radel® PPSU 
Udel® PSU
Veradel®
HC PESU
Ixef®
PARA
Complete 
characterization(1)
ISO 10993-18        
Physico-chemical ISO 10993-18  √
Cytotoxicity ISO 10993-5  √  √  √
Sensitization ISO 10993-10  √  √  √  √
Intracutaneous toxicity ISO 10993-10  √  √  √  √
Acute systemic toxicity ISO 10993-11  √  √  √  √
Subchronic toxicity ISO 10993-11  √  √        
Genotoxicity ISO 10993-3        
Bone and muscle 
implant tests
ISO 10993-6 Muscle        
Hemolysis ASTM F-756        
Pyrogenicity USP 151  √  √        

(1)Including exhaustive extractions and risk assessment

 

Technical Data Sheets
Radel® R-5000 Transparent, general purpose for injection molding
Veradel® HC A-301 Transparent, rigid, high-temperature, high-flow grade for injection molding
Udel® P-1700 Transparent, general purpose for injection molding
Udel® GF-120 20% glass fiber
Ixef® 1022 50% glass fiber, general purpose for injection molding
AvaSpire® AV-651 Better ductility and higher HDT than comparable PEEK, high melt flow for injection molding
AvaSpire® AV-651 GF30 30% glass fiber, better chemical resistance than AV-621, high melt flow for injection molding
AvaSpire® AV-651 CF30 30% carbon fiber, high melt flow for injection molding
KetaSpire® KT-880 High melt flow for injection molding, lubricated
KetaSpire® KT-880 GF30 30% glass fiber, high melt flow for injection molding
KetaSpire® KT-880 CF30 30% carbon fiber, high melt flow for injection molding

Contact your Solvay representative for information specific to Solviva® Biomaterials

Technical & Regulatory Support

At Solvay, we understand the importance of responsive customer support and work hard to earn your confidence in us as a materials supplier. Our dedicated healthcare team provides the product development, technical and regulatory support you need to grow your global business. Please contact us for assistance with:

  • Material recommendations
  • Designing with plastics
  • Moldflow® process modeling
  • Finite element analysis
  • Fabrication and assembly techniques
  • Product testing
  • Failure analysis
  • Global regulatory submission assistance