Medical Devices Laboratories

Biomaterials Testing
of Tissues Testing
Bone and Joint Computer Modeling Testing
Ethylene Oxide Biological Indicators Performance Testing
GHG Emissions Testing
Implantable Medical Device Testing
In-Vitro Diagnostic Testing
Precision Testing
Sensitivity Testing
Specificity Testing
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 Product Services

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

• 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 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 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
• 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
• 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

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