Compliance Engineering Services
"Taking the bite out of Regulatory Issues"
Fair Consulting, provides compliance engineering expertise and experienced personnel to support your engineering requirements!
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Compliance Standards



  • USA
  • European
  • International

  • Medical

      USA
      • ANSI/AAMI ES 60601-1:2005 (USA)
      • AIMD 90/385/EEC The active implantable medical devices directive
      • IVD 95/C172/02 Vitro diagnostic products
      • NFPA 99 Standard for Health Care Facilities
      • FDA CFR 21 Parts 800-1299 MEDICAL DEVICES
      • FDA CFR 21 SUBCHAPTER H - MEDICAL DEVICES
      • FDA CFR 21 Part 880.5510 Non-AC-powered patient lift.
      • FDA Guidance - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.
      • UL1431 Personal Hygiene and Health Care Appliances
      • UL1069 Hospital Signaling and Nurse Call Equipment
      • UL1047 Isolated Power Systems Equipment
      • UL1331 Station Inlets and Outlets
      • UL863 Time-Indicating and -Recording Appliances
      • UL60950 Information Technology Equipment – Safety
      • Fire
        • BFD IX-11 MATTRESS FIRE TEST (Boston Fire Department).
        • California Technical Bulletin 129, and 16 FLAMMABILITY TEST PROCEDURE FOR MATTRESSES FOR USE IN PUBLIC BUILDINGS
        • CFR 1632 Smolder Resistance of Mattresses and Futons 
        • CFR 1633 Flame Resistance of Residential Mattresses and Futons
        • ASTM E 1590 Fire Testing of Mattresses
        • UL1895 Mattress
        • NFPA 267, Standard Method of Tests for Five Characteristics of Mattresses and Bedding Assemblies Exposed to Flaming Ignition Source
      Canada
      • CAN/CSA-C22.2 No. 60601-1:08 (Health Canada).
      EU
      • MDD - The Medical devices Directive 93/42/EEC
      • 2007/47/EC Medical Device Directive
      • EN 60601-1:2006 (EU)
      • DOP – 2006-09-12 (EU)
      • DOW – 2009-09-12 (EU)
      International
      • IEC513 Safety Medical Electrical Equipment
      • IEC 601 series to prove that the device itself does constitute an electrical hazard.
      • IEC60601-1 Medical Electrical Equipment
      • IEC60601-1-1 Systems (Incorporated into the 3rd Edition)
      • IEC60601-1-2 EMC (Incorporated into the 3rd Edition).
      • IEC60601-1-3 Radiology
      • IEC60601-1-4 Programmable Electrical Medical Systems - PEMS (Incorporated into the 3rd Edition).
      • IEC60601-1-6 Usability
      • IEC60601-1-8 Alarm Systems
      • IEC60601-1-9 Environment
      • IEC60601-1-10 Closed loop controllers.
      • Draft 60601-1-11 Home health care
      • IEC60601-2-38 Hopsital Beds
      • IEC60601-2-52 Hopsital Beds
      • IEC60417-SN Graphical Symbols
      • IEC60529 IP Code
      • IEC60664-1 Insulation Coordination
      • IEC60825-1 Laser Products
      • IEC TR60878 Graphical symbols
      • IEC60959-1 Information Technology Equipment
      • BS 7177 British Standard Specification for Resistance to Ignition of Mattresses, Divans and Bed Bases.
      • MHLW (Japan)
      • TGA (Australia)

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