Sterile medical devices are essential tools in healthcare, designed to be free from all forms of viable microorganisms. These devices are crucial for preventing infections and ensuring patient safety during medical procedures. Sterility is achieved through stringent manufacturing processes and sterilization techniques.
Medical Devices - Sterile Testing and Research Services
Contract Laboratory can help you with all your Medical Devices - Sterile testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
Sterility Testing (Bacterial Endotoxin Test
Bioburden Test)
Packaging Integrity Testing
Biological Indicator Testing
Sterilization Process Validation
Pyrogen Testing
Accelerated Aging Studies
Ethylene Oxide Residuals Testing
Radiation Sterilization Dosimetry
Chemical Indicator Testing
Shelf-Life Stability Testing
Type of Medical Devices - Sterile 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 - Sterile finished products, processes, systems, in-process materials, raw materials and components such as:
Surgical Instruments (Scalpels
Forceps
Scissors)
Hypodermic Needles and Syringes
Catheters
Implantable Devices (Pacemakers
Stents)
IV Tubing and Bags
Wound Dressings and Bandages
Surgical Drapes and Gowns
Sterile Gloves
Sterile Sutures
Sterile Packaging Materials
Medical Devices - Sterile Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Medical Devices - Sterile test methods, standards, procedures or specifications.
ANSI 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
ANSI TIR10993-19:2006 - Biological evaluation of medical devices - Part 19: Physio-chemical
ASTM F3014 - Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
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 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 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
ASHRAE 11607 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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
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 127 - Dynamic Loading Test for Endosseous Dental Implants
ADA 127 - Dynamic Loading Test for Endosseous Dental Implants
ADA ST55 - Table-top Steam Sterilizers
ISO 11979 - Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility
ASTM F1929-15 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F2477-19 - Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
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 F3223-17 - Standard Guide For Characterization And Assessment Of Tissue Engineered Medical Products (TEMPs) For Knee Meniscus Surgical Repair And/Or Reconstruction
ASTM F1185-03(2014) - Standard Specification for Composition of Hydroxylapatite for Surgical Implants
Need Medical Devices - Sterile Testing or Scientific Research Services?
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