Introduction
The medical equipment & supplies laboratory is one of the specialized laboratories of FDCRL which is responsible for the technical inspection of medical equipment, supplies and evaluation of their compliance with local and international standards such as ISO, IEC, AAMI, ANSI, CLSI, and ASTM. The purpose of these inspections is to assure the basic safety and essential performance of medical devices. Besides, this laboratory is responsible for the inspection and auditing of collaborating laboratories.
In addition to the above-mentioned tasks and activities, medical equipment & supplies laboratory does the research on novel testing procedures for devices without defined and established standards. It also updates the testing procedures according to the recently updated standards.
 
Personnel Expertise
Ph.D. in Bio-mechanic engineering and Toxicology
MSc in Bio-electric engineering, Bio-mechanic engineering, Medical radiation engineering and Immunology
BSc in Electrical engineer and Electronics engineering
 
Scope
  • Evaluation of medical equipment protection against:
    • Excessive temperature
    • Electrical hazards of medical electrical equipment (di-electric strength, leakage currents, defibrillator proof protection, protective earthing)
    • Mechanical hazards of medical electrical equipment (vibration, instability, pneumatic and hydraulic pressure)
    • Harmful ingress of water or particulate matter (IP Code)
    • Unwanted and excessive radiation
 
 
  • Evaluation of:
    • Labeling, marking and documentation of medical electrical equipment
    • Accuracy of monitoring and controlling devices and protection against dangerous output levels Hazardous and fault conditions
    • Software life cycle of medical equipment
    • Electromagnetic compatibility (EMC)
    • Bio-compatibility (toxicity and irritability)
    • Physicochemical & Microbial tests of pharmaceutical supplies
 
Analysis & Tests
Devices which are tests routinely included:
  • Anticoagulants
  • Blood collection device
  • Cardiovascular equipment
  • Dental equipment
  • Disposable medical supplies
  • Disinfectants
  • Eye drops
  • High frequency surgical equipment
  • Hemostatic pads
  • Infusion pumps
  • Imaging equipment
  • Implantable devices
  • Injectable gels
  • Liquid lens cleaner
  • Medical laboratory's diagnostic kit and equipment
  • Orthopedic and physiotherapy devices
  • Suctions
  • Skin filler
 
 
Medical Device Test Equipment
The laboratory experts apply several types of equipment to assure not only the functionality and likely work-related problems of medical devices but also the safety of medical supplies. This equipment includes:
  • Bain-marie
  • CO2 incubator
  • Electro-surgery tester
  • Elisa reader
  • Flow-cytometer
  • Gas Chromatography
  • HV di-electric strength
  • High performance Liquid Chromatography
  • Inverted microscope
  • Infusion pump tester
  • Laminar & chemical hood
  • NIBP Tester
  • Oscilloscope
  • Potentiometer
  • Power meter
  • Refrigerated centrifuge
  • Spectrometer (UV, Fluorescence)
  • Ventilator analyzer
  • Vital sign simulator