ContractLaboratory.com can assist your medical device manufacturer, organization, academic institution, or government agency in outsourcing independent, commercial contract laboratories and contract research organizations (CRO) to do all your routine and non-routine Medical Devices and In-Vitro Diagnostics testing, medical device analysis, medical device certification, medical device experiments and medical device research and medical device development studies.
Medical Devices, In-Vitro Diagnostics, biomedical, biophysical, bio mechanical studies, research, development, experimentation, evaluations, analysis, and testing. Some medical device certification
Medical Devices Testing and Research Services
Contract Laboratory can help you with all your Medical Devices testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
Medical Device AATCC and ASTM Antimicrobial Testing
Medical Device ASTM Extractable Testing
Medical Device Barrier Testing
Medical Device Bioburden Testing
Total Aerobes Testing
Total Coliforms Testing
Total Fungi Testing
Medical Device Biodegradation Subchronic Toxicity Studies Testing
Medical Device Biomaterial Extracts Protein Assays Testing
Medical Device Carcinogenicity Testing
Medical Device Compliance Testing
Medical Device Container/Closure Testing
Medical Device Contamination Testing
Medical Device Design and Modeling of Systems Medical Device Environmental Monitoring Testing
Medical Device Ex-Vivo Hemocompatibility Studies Medical Device Finished Product Quality Control Testing
Medical Device Genotoxicity Ames Testing
Medical Device Genotoxicity Chromosomal Aberration Testing
Medical Device Histopathology Testing
Medical Device ISO 10993-1 (FDA GP 95-1) Biological Safety Testing
Medical Device In-Vitro Biocompatibility Studies Testing
Medical Device In-Vivo Biocompatibility Studies Medical Device In-Vivo Hemocompatibility Studies Testing
Medical Device Irritation Studies Testing
Medical Device Leachable Testing
Medical Device Microbial Identifications Testing
Medical Device Mutagenicity Testing
Medical Device Particles Analysis Testing
Medical Device Particulate Testing
Medical Device Physical Testing
Medical Device Preclinical Testing
Medical Device Product Inoculations Testing
Medical Device Product Safety Testing
Medical Device Radiological Testing
Medical Device Sensitization Testing
Medical Device Shipping Validations and Shipping Testing
Medical Devices Impact Resistance Testing
Simulated Use Testing
Medical Device Stability Studies Testing
Medical Devices Accelerated Aging Stability Studies Medical Devices Real Time Stability Studies Medical Device Sterility Testing
Medical Device Sterilization Dose Validation Medical Device Sterilization Validation Medical Device Tensile Testing
Medical Device Thermal Analysis Testing
Medical Device USP Implantation Studies Medical Device USP Microbial Limits Testing
Medical Device USP and EP Plastics and Container Testing
Medical Device USP Glass Container Testing
Medical Device USP Polyethylene Container Testing
Medical Device USP Testing
AAMI Testing
EP Bacteriostasis/Fungistasis Testing
Medical Devices Analytical Chemistry Testing
Medical Devices Bacterial Endotoxin Testing
- Gel Clot Testing
Medical Devices Bacterial Endotoxin Testing
- Limulus Amebocyte Lysate LAL Testing
Medical Devices Biomaterials Testing
Medical Devices Biomechanical Platform Testing
Medical Devices Biomechanical Testing
Medical Devices Biomedical Testing
Medical Devices Biomedical Testing
Medical Devices Biophysical Characterization Testing
Medical Devices Biophysical Properties Testing
Medical Devices Biophysical Testing
Medical Devices Cleaning Validation Testing
Medical Devices Conformity Assessments Testing
Medical Devices Cytotoxicity Testing
Medical Devices Electrical Safety Testing
Medical Devices Electromagnetic Compatibility Testing
EMC Testing
Medical Devices Ethylene Oxide Residuals Testing
Medical Devices Failure Analysis Testing
Medical Devices Fatigue Testing
Medical Devices Fatigue Testing
Medical Devices Foreign Materials Testing
Medical Devices In-Vivo USP Testing
JP Testing
EP Pyrogen Testing
Medical Devices Leak Testing
Medical Devices Materials Characterization Testing
Medical Devices Methods Development and Validation Testing
Medical Devices Microbiology Testing
Medical Devices Packaging Studies and Testing
Medical Device Package Integrity Testing
Medical Device Packaging Burst Testing
Medical Device Packaging Creep Testing
Medical Device Packaging Dye Penetration Testing
Medical Device Packaging Peel Testing
Medical Device Packaging Vacuum Leak Testing
Medical Devices Safety Evaluations Testing
Medical Devices Toxicology Testing
Medical Devices Transportation Simulation Testing
Medical Devices Vibration Testing
Medical Products Re-engineering Testing
Medical Products Reverse Engineering Testing
Reusable Device Studies Testing
Reusable Medical Devices Testing
RoHS Testing
Steam Biological Indicators Performance Testing
USP Purified Water Testing
USP Water for Injection Testing
WEEE Testing
Type of Medical Devices 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 Devices finished products, processes, systems, in-process materials, raw materials and components such as:
pediatric medical devices
in-vitro diagnostic devices
sterile implantable medical devices
orthopedics
pacemakers
stents
artificial hearts
knee replacements
hip replacements
physical medicine devices
radiology devices
nuclear medicine devices
NMR
CAT scanning machines
PET scanning machines
disposable medical devices
contact lenses
hearing aids
cochlear implants
blood glucose meters
pregnancy test kits
latex gloves
breast implants
surgical gloves
condoms
intraocular lenses
glasses
IV
needles
blood bags
reproductive devices
nebulizers
mammography machines
single-use medical devices
electrical medical devices
biological medical devices
X-Ray Systems
wireless medical telemetry
lasers
anesthesiology medical devices
surgical devices
sutures
angioplaty devices
apnea monitors
catheters
defibrillators
aneurysm clips
dressings
cardiovascular medical devices
ear
nose and throat medical devices
orthopedic medical devices
microbiology medical devices
opthalmic medical devices
pathology medical devices
toxicology medical devices
dental medical devices
immunology medical devices
neurology medical devices
surgery medical devices
plastic medical devices
medical gases
reusable medical devices
hospital beds
wheelchairs
Medical Devices Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Medical Devices 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
ISO 22882:2016 - Castors and wheels -- Requirements for castors for hospital beds
ISO 22609:2004 - Clothing for protection against infectious agents -- Medical face masks -- Test method for resistance against penetration by synthetic blood (fixed volume
ISO 21171:2006 - Medical gloves -- Determination of removable surface powder
ISO 11193-2:2006 - Single-use medical examination gloves -- Part 2: Specification for gloves made from poly(vinyl chloride)
ISO 10282:2014 - Single-use sterile rubber surgical gloves -- Specification
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 8600 - Endoscopes Medical endoscopes and endotherapy devices
ISO 7886 - Sterile hypodermic syringes for single use
ISO 7376:2009 - Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
ISO 7151:1988 - Surgical instruments Non-cutting
ISO 1135 - Transfusion equipment for medical use
IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
AS 3695 - Wheelchairs, Part 2: Requirements and test methods for electrically powered wheelchairs (including mobility scooters)
AS 4187 - Reprocessing of reusable medical devices in health service organisations
AS 4187 - Reprocessing of reusable medical devices in health service organisations
ASTM F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 16755 - ackaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ASTM F2475 - Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
ISO 11137 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 5833 - Implants for surgery - Acrylic resin cements
ISO 16402 - Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics
ASTM D7661 - Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
EN 13612: - Performance evaluation of in-vitro diagnostic devices
ISO 4074 - Natural latex rubber condoms Requirements and test methods
ISO 7176 - Wheelchairs
ISO 8669 - Urine collection bags
ISO 5356-1 - Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets
IEEE 1708 - IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices
IEC 60601 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10993 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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 11.040.01 - Medical equipment in general
IEC 80601-2-35:2009 - Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets
IEC 60601-2-52:2009 - Medical electrical equipment -- Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
ISO 11137 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ASTM F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM 10993 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ASTM - Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
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 F451-16 - Standard Specification for Acrylic Bone Cement
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 F565-04(2018) - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ASTM F623-99(2013) - Standard Performance Specification for Foley Catheter
ASTM F640-12 - Standard Test Methods for Determining Radiopacity for Medical Use
ASTM F641-09(2014) - - Standard Specification for Implantable Epoxy Electronic Encapsulants
ASTM F700-93(2014) - Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
ASTM F702-18 - Standard Specification for Polysulfone Resin for Medical Applications
ASTM F719-81(2012) - Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
ASTM F720-17 - Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
ASTM F746-04(2014) - Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F749-13 - Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
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
ASTM F813-07(2012) - Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
IEC 80601-2-35:2009 - Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
ISO 18562-3:2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs)
ISO 18562-4:2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 4: Tests for leachables in condensate
ISO 10282:2014 - Single-use sterile rubber surgical gloves
ISO 11193-1:2008 - Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution
ISO 21171:2006 - Medical gloves - Determination of removable surface powder
ISO 22609:2004 - Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
ASTM E1061 - Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
ASTM - Standard Specification for Polysulfone Resin for Medical Applications
ASTM E2995 - Standard Specification for ASTM Thermohydrometers with Integral Low-Hazard Thermometers
ASTM F1830 - Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
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 14243 - Wear of total knee-joint prostheses
ISO 14801 - Dynamic fatigue test for endosseous dental implants
ISO 14879 - Total knee-joint prostheses, Part 1: Determination of endurance properties of knee tibial trays
ISO 17853 - Wear debris is retrieved and subject to particle analysis
ISO 18192 - Wear of total intervertebral spinal disc prostheses
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 7176 - Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176 - Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 14708 - Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
IEEE 11073 - IEEE Standard - Health Informatics - Personal Health Device Communication - Part 10404: Device Specialization - Pulse Oximeter
IEEE 11073-10404-2011 - Health informatics--Personal health device communication Part 10406: Device specialization--Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE 11073-10420 - EEE Health informatics -- Personal health device communication Part 10420: Device specialization -- Body composition analyzer
IEEE 11073-10421 - IEEE Standard - Health informatics--Personal health device communication Part 10421: Device specialization--Peak expiratory flow monitor (peak flow)
IEEE 11073-10422 - Health informatics--Personal health device communication Part 10422: Device Specialization--Urine Analyzer
IEEE 11073-19425 - IEEE Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM)
IEEE 11073-10441 - IEEE/ISO International Standard - Health Informatics - Personal Health Device Communication - Part 10441: Device Specialization - Cardiovascular Fitness and Activity Monitor
IEEE 11073-10472 - Health informatics--Personal health device communication--Part 10472: Device specialization--Medication monitor
IEEE 1708 - IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices
IEEE 2010 - IEEE Recommended Practice for Neurofeedback Systems
IEEE 790 - IEEE Guide for Medical Ultrasound Field Parameter Measurements
ISO 80601 - Medical electrical equipment-Part2-67:Particular requirements for basic safety and essential performance of oxygen-conserving equipment
ASHRAE 11607 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 80369 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 11737 - Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 16146 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 8536 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 60601 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
ISO 22442 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
ISO 11608 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
ISO 11608 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
IEEE C63 - Methods of Measurement for Hearing Aid Compatibility with Wireless Communications
IEEE C63 - On-site, Ad-Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio Frequency Transmitters
CSA Z316 - Sharps injury protection - Requirements and test methods - Sharps containers
CSA C22.2 NO. 80601-2-80:20 - Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
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
ADA 46 - Dental Patient Chair
ADA 41 - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
ADA 130 - Dentifrices - Requirements, Test Methods and Marking
ISO 11979 - Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility
ASTM F2884-12 - Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F1929-15 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F3106-14 - Standard Guide for in vitro Osteoblast Differentiation Assays
ASTM F2477-19 - Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
ASTM F1635-16 - Standard Test Method for ?in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
ASTM F640 - 20 - Standard Test Methods for Determining Radiopacity for Medical Use
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 F3223-17 - Standard Guide For Characterization And Assessment Of Tissue Engineered Medical Products (TEMPs) For Knee Meniscus Surgical Repair And/Or Reconstruction
ASTM F2903-11 - Standard Guide For Tissue Engineered Medical Products (TEMPs) For Reinforcement Of Tendon And Ligament Surgical Repair
ASTM E1061-01(2014) - Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
ASTM F1185-03(2014) - Standard Specification for Composition of Hydroxylapatite for Surgical Implants
ISO 10651 - LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
ISO 80601 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
Medical Devices Certifications, Licenses, and Accreditations:
Depending on your Medical Devices products, you may need third-party Medical Devices laboratories or research facilities with specific certifications, licenses or accreditations.
FDA
MDD
USP
CMDCAS
INMETRO
BP
JP
IEC
AIMDD
IVDD
US FDA
GLP
GMP
QSR
EMC
CE
ASTM
AAMI
NIST
QSR
NRTL
UKAS
BS
ISO
IEEE
A2LA
CAEL
UL
JIS
OHSAS
ISO/TS
WEE
RoHS
CLIA
FDA
USP
ASTM
AAMI
AATCC
EP
GCP
UL/ANSI
IEC
CISPR
TUV
Caption: Surgical Instrument Cleaning Validation
Caption: Medical Equipment Design
Caption: Wheelchair Testing
Need Medical Devices Testing or Scientific Research Services?
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