Medical Devices Laboratories

Medical Devices Testing and Scientific Research

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 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 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

Medical Devices Test Method and Standards:

Medical Devices products maybe tested according to many different Medical Devices Test Method and Standards including:

ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements.

ANSI/AAMI/ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers

implantable cardioverter defibrillators

and cardiac resynchronization devices.

AAMI TIR42:2010 Evaluation of particulates associated with vascular medical devices

ANSI/AAMI/ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.

ANSI/AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

AAMI/ISO TIR16142-1:2016 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

AAMI/ISO TIR37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants.

AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices - Part 19: Physio-chemical

morphological and topographical characterization of materials

ANSI/AAMI/ISO 10993-6:2016 Biological evaluation of medical devices?Part 6: Tests for local effects after implantation

ANSI/AAMI/ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices-Part 3: Tests for genotoxicity

carcinogenicity

and reproductive toxicity

ANSI/AAMI/ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices

Part 17: Establishment of allowable limits for leachable substances.

ANSI/AAMI/ISO 10993-15:2000/(R)2011 Biological evaluation of medical devices

Part 15: Identification and quantification of degradation products from metals and alloys.

ANSI/AAMI/ISO 10993-14:2001/(R)2011 Biological evaluation of medical devices

Part 14: Identification and quantification of degradation products from ceramics.

ANSI/AAMI/ISO 10993-13-2010/(R)2014 Biological evaluation of medical devices

Part 13: Identification and quantification of degradation products from polymeric devices.

ANSI/AAMI/ISO 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

pads or mattresses and intended for heating in medical use

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

horizontally projected)

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 11193-1:2008 Single-use medical examination gloves -- Part 1: Specification for gloves made from rubber latex or rubber solution

ISO 10282:2014 Single-use sterile rubber surgical gloves -- Specification

ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers

haemodiafilters

haemofilters and haemoconcentrators

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 7864:2016 Sterile hypodermic needles for single use ? Requirements and test methods

ISO 7376:2009 Anaesthetic and respiratory equipment ? Laryngoscopes for tracheal intubation

ISO 7151:1988 Surgical instruments Non-cutting

articulated instruments General requirements and test methods

ISO 5358:1992 Anaesthetic machines for use with humans

ISO 1135 Transfusion equipment for medical use

IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ISO 10993

ISO 10993-1

ASTM D7661 - 10(2017) 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 8670 Ostomy collection bags

ISO 5356-1 Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets

Medical Devices

Contract Laboratory can help you with all your Medical Devices testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development of many Medical Devices finished products, processes, systems, in-process materials, raw materials and components including.

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

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 Certifications, Licenses, or 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

IEC

AIMDD

IVDD

US FDA

GLP

GMP

QSR

EMC

ASTM

AAMI

NIST

QSR

NRTL

UKAS

ISO

IEEE

A2LA

CAEL

JIS

OHSAS

ISO/TS

WEE

RoHS

CLIA

FDA

USP

ASTM

AAMI

AATCC

GCP

UL/ANSI

IEC

CISPR

TUV

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Medical Devices Testing, Analysis, Assays, Scientific Research, Experiments, Inspections and Certifications

Medical Devices Testing, Analysis, Assays, Scientific Research, Experiments, Inspections and Certifications

Medical Devices Testing, Analysis, Assays, Scientific Research, Experiments, Inspections and Certifications

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Medical Devices Testing and Scientific Research

Medical Devices Test Method and Standards:

Medical Devices

Medical Devices Certifications, Licenses, or Accreditations:

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