Medical Implants Lab Testing and Scientific Research

Biocompatiability Testing
Degradation Testing
Endurance Properties Testing
Radiopacity for Medical Use Testing
Contact Allergens Testing
Primary Skin Irritation Testing
Direct Contact Cell Culture Evaluation Testing
Hemolytic Properties Testing
Total Joint Prostheses Testing
compression Testing
tension Testing
shear Testing
particle analysis Testing
ion release Testing
corrosion Testing
fretting corrosion analysis Testing
Tissue Compatibility Testing
Cell Compatibility Testing
Gravimetric Wear Assessment Testing
Cyclic Fatigue Testing
Stereological Evaluation Testing
Biological Response to Particles In Vitro Testing
Selected Tissue Effects Testing
Accelerated Aging Testing
Transformation Temperature Testing
Intrinsic Elastic Recoil Testing
Corrosion Susceptibility Testing
Delayed Contact Hypersensitivity Testing
Degree of Deacetylation Testing
Burst Strength Testing
Wound Closure Strength Testing
Behind-the-Knee (BTK) Skin Irritation Testing
Hemocompatibility Assessment Testing
Neurotoxicity Testing
Small Punch Testing
Spread of Fixed Cells Testing
Galvanic Corrosion Testing
Cell-Material Adhesive Interactions Testing
Collagen-Cell Interactions Testing
Osteoblast Differentiation Assays Testing
Cleaning Process Validation Testing
Testing

Type of Medical Implants Products

Contract Laboratory can assist your company, academic institution, government agency or organization in outsourcing contract laboratories to perform testing, analysis, and product development for many Medical Implants finished products, processes, systems, in-process materials, raw materials and components such as:

Artificial Organs
Hip Joint Prosthesis
Hip Implants
Knee Implants
Dental Implants
Bone Plates
Bone Screws
Resin Cements
Vascular Grafts
Catheters
Cardiovascular Implants
Cardiac Pacemakers
Stents
Osteosynthesis
Skeletal Pins
Skeletal Wires
Bone Cements
Bone Staples
Fouorescent Penetrant Inspection
Biomaterials
Implantable Shunts
Implantable Epoxy Electronic Encapsulants
Aneurysm Clips
Implantable Breast Prostheses
Facial Implants
Orofacial Prosthetic
Medical Coatings
Soft Tissue Expanders
Glass Ceramic Biomaterials
Ceramic Biomaterials
Glass Biomaterials
Skeletal Fixation Devices
Patellar Prosthesis
Spinal Implants
Ureteral Stents
Blood Pumps
Halo External Spinal Immobilization Devices
Continuous Flow Blood Pumps
Surgical Sutures
Total Hip Joint Prosthesis
Implantable Saline Filled Breast Prosthesis
Tissue Engineered Medical Products
Femoral Prostheses
Intervertebral Body Fusion Devices
Balloon-Expandable Stents
Vascular Stents
Acetabular Prostheses
Acrylic Bone Cement
Biomaterial Scaffolding
Implantable Strands and Cables
Tissue Adhesives
Surgical Sealants
Implantable Middle Ear Hearing Devices
Enteral Feeding Devices
Demineralized Bone (DBM)
Total Ankle Replacement Prosthesis
Tracheal Tubes
Cast Metallic Implants
Hydrogels
Absorbable Polymeric Implants
Endovascular Devices
Musculoskeletal Implants

• ASTM 27186:2010 - Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements.
• ANSI 14117:2012 - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers
• AAMI TIR42:2010 - Evaluation of particulates associated with vascular medical devices
• ANSI 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
• ISO - Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants.
• ISO 10993-20:2006 - Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
• ANSI 10993-6:2016 - Biological evaluation of medical devices Part 6: Tests for local effects after implantation
• ANSI 10993-5:2009/(R)2014 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
• ANSI 10993-3:2014 - Biological evaluation of medical devices-Part 3: Tests for genotoxicity
• ANSI 10993-14:2001/(R)2011 - Biological evaluation of medical devices
• ANSI 10993-13-2010/(R)2014 - Biological evaluation of medical devices
• ANSI 10993-10:2010/(R)2014 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
• ISO 8637:2010 - Cardiovascular implants and extracorporeal systems Haemodialysers
• ISO 8615:1991 - Implants for surgery Fixation devices for use in the ends of the femur in adults
• ISO 11137 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ASTM 10993 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
• ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F75-18 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• ASTM F543-17 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• ASTM F623-99(2013) - Standard Performance Specification for Foley Catheter
• ASTM F641-09(2014) - - Standard Specification for Implantable Epoxy Electronic Encapsulants
• ASTM F648-14 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• ASTM F700-93(2014) - Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
• ASTM F703-18 - Standard Specification for Implantable Breast Prostheses
• ASTM F746-04(2014) - Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
• ASTM F750-87(2012) - Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
• ASTM F756-17 - Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F763-04(2016) - Standard Practice for Short-Term Screening of Implant Materials

Medical Implants Certifications, Licenses, and Accreditations:

Depending on your Medical Implants products, you may need third-party Medical Implants laboratories or research facilities with specific certifications, licenses or accreditations.

ASTM
ISO
AAMI
ASME