There are a variety of medical implants in use today and many more are being developed. The testing of these implants is one of the most important tools for the safety of these devices. Different types of implants can require different tests and will need different certifications.
The testing of medical implants is a process that analyzes various aspects of the implants before they are certified for clinical use. Depending on the product it may be analyzed for chemical composition, particle analysis, ion release, physical capabilities and more.
Medical Implants Laboratory Testing and Scientific Research:
Medical Implants Testing and Research Services
Contract Laboratory can help you with all your Medical Implants testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
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
Medical Implants Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Medical Implants test methods,standards, procedures or specifications.
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
ISO 29701:2010 - Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test
ISO 23034 - Method to estimate cellular uptake of carbon nanomaterials using optical absorption
ISO 11607 - Packaging for terminally sterilized medical devices
IEC 12417 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
BS 556 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices
ISO 16402 - Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics
ASTM F2884 - Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F981 - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
ASTM F3141 - Standard Guide for Total Knee Replacement Loading Profiles
ASTM F3211 - Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
ASTM F756 - Standard Practice for Assessment of Hemolytic Properties of Materials
ISO 14801 - Dynamic fatigue test for endosseous dental implants
ISO 25539 - Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
ISO 7198 - Cardiovascular implants and extracorporeal systems -- Vascular prostheses -- Tubular vascular grafts and vascular patches
ISO 7206 - Implants for surgery -- Partial and total hip joint prostheses -- Part 4: Determination of endurance properties and performance of stemmed femoral components
ISO 7206 - Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ISO 14708 - Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
ISO 14708 - Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
ISO 14708 - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
ISO 14708 - Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
CSA C22.2 NO. 60601-2-31:20 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
ADA 173 - Designation System for Dental Implants
ADA 127 - Dynamic Loading Test for Endosseous Dental Implants
ADA 127 - Dynamic Loading Test for Endosseous Dental Implants
ISO 11979 - Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility
ASTM F2884-12 - Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F1635-16 - Standard Test Method for ?in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
ASTM F601-18 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
ASTM F629-20 - Standard Practice for Radiography of Cast Metallic Surgical Implants
ASTM F2212-19 - Standard Guide For Characterization Of Type I Collagen As Starting Material For Surgical Implants And Substrates For Tissue Engineered Medical Products (TEMPs)
ASTM F2903-11 - Standard Guide For Tissue Engineered Medical Products (TEMPs) For Reinforcement Of Tendon And Ligament Surgical Repair
ASTM F2903-11 - Standard Guide For Tissue Engineered Medical Products (TEMPs) For Reinforcement Of Tendon And Ligament Surgical Repair
ASTM F1185-03(2014) - Standard Specification for Composition of Hydroxylapatite for Surgical Implants
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
Implantable Medical Device Testing
Bone Fixation Plate Testing
Need Medical Implants Testing or Scientific Research Services?
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