Reusable medical devices are designed for multiple uses in clinical settings, requiring stringent protocols for cleaning, sterilization, and maintenance to ensure patient safety and device longevity. These devices are essential for various medical procedures, from diagnostics to treatment, offering cost-effective and sustainable healthcare solutions.
Medical Devices (Reusable) Testing and Research Services
Contract Laboratory can help you with all your Medical Devices (Reusable) testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
Sterility Assurance Testing
Material Compatibility Testing
Functional Performance Testing
Microbial Load Testing
Chemical Residue Testing
Biocompatibility Testing
Reprocessing Validation (Cleaning
Disinfection
Sterilization)
Endurance and Durability Testing
Visual Inspection for Wear and Tear
Surface Cleanliness Testing
Type of Medical Devices (Reusable) 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 (Reusable) finished products, processes, systems, in-process materials, raw materials and components such as:
Surgical Instruments (Scalpels
Forceps
Scissors)
Endoscopes
Dental Instruments
Reusable Syringes
Anesthesia Breathing Circuits
Dialysis Machines
Reusable Surgical Drapes and Gowns
Diagnostic Devices (Ophthalmoscopes
Otoscopes)
Hemodialysis Filters
Infusion Pumps
Medical Devices (Reusable) Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Medical Devices (Reusable) 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
ANSI 10993-14:2001/(R)2011 - Biological evaluation of medical devices
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 8600 - Endoscopes Medical endoscopes and endotherapy devices
ISO 7864:2016 - Sterile hypodermic needles for single use Requirements and test methods
ISO 7151:1988 - Surgical instruments Non-cutting
ISO 11137 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ASTM - Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
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 60118 - Electroacoustics - Hearing aids
AS 4187 - Reprocessing of reusable medical devices in health service organisations
AS 4187 - Reprocessing of reusable medical devices in health service organisations
ISO 11737 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 62353 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment