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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)

    Acoustic

      International
      • ISO 7779:2010 Superseeded Acoustics — Measurement of airborne noise emitted by information technology and telecommunications equipment.
      • ISO 7779:2018-11 Current Acoustics — Measurement of airborne noise emitted by information technology and telecommunications equipment.
      • ISO 9296:2017 Current Acoustics — Declared noise emission values of information technology and telecommunications equipment.
      • ISO 3744:2010 Current Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane.
      • IEC 61672-1:2013 2013 Electroacoustics - Sound level meters - Part 1: Specifications.
      EU
      • ETS 300 753 V1.3.1 2011-11 Equipment Engineering (EE); Acoustic noise emitted by telecommunications equipment.

    Environmental

      International
      • IEC 60068-2-64: Random Vibration Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
      • IEC 60068-2-29: Shocks, Type I / II Environmental testing - Part 2: Tests - Test Eb and guidance: Bump
      • IEC 60068-2-32: Fall Test Amendment 2 - Environmental testing. Part 2: Tests. Test Ed: Free fall
      USA
      • MIL-STD-810H, Method 501.5 Old High Temperature
      • MIL-STD-810H, Method 502 Old Low Temperature
      • MIL-STD-810H, Method 503.5 Old Thermal Shock
      • MIL-STD-810H, Method 507.5 Old Humidity
      • MIL-STD-810H, Method 501.7 Current High Temperature
      • MIL-STD-810H, Method 502.7 Current Low Temperature
      • MIL-STD-810H, Method 503.7 Current Temperature Shock
      • MIL-STD-810H, Method 507.6 Current Humidity
      • MIL-STD-202F Old TEST METHOD STANDARD ELECTRONIC AND ELECTRICAL COMPONENT PARTS
      • MIL-STD-202H Current TEST METHOD STANDARD ELECTRONIC AND ELECTRICAL COMPONENT PARTS
      • MIL-STD-883L Current TEST METHOD STANDARD MICROCIRCUITS
      • MIL-STD-810G, Method 516.6 Old Shock
      • MIL-STD-810G, Method 514.6 Old Vibration
      • MIL-STD-810H Method 514.8 Current Vibration
      • MIL-STD-810H Method 516.8 Current Shock

    Ecology

      International
      • IEC 63000 Edition 1 2016-10 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.
      • ISO 14000 Environmental management systems — Requirements with guidance for use.
      • IEC 62474:2018 Material declaration for products of and for the electrotechnical industry.
      USA
      • Cal Prop 65 Restrictions on Toxic Discharges into Drinking Water; Requirementof Notice of Persons' Exposure to Toxics. Initiative Statute.
      EU
      • RoHS 2011/65/EU (recast) Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS).
      • REACH 12/18/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
      • WEEE 8/24/2024 Waste from Electrical and Electronic Equipment (WEEE).
      China
      • GB 18455-2001 Packaging Recycling Marks.

    Packing

      International
      • ASTM D4169 Standard practice for performance testing of shipping containers and systems.
      • ASTM D7386 Standard practice for performance testing of packages for single parcel delivery systems.
      • ISTA 1A, 1B, 1C, 1D, 1E, 1G, 1H Non-simulation integrity performance tests.
      • ISTA 2A, 2B, 2C Partial simulation performance tests.
      • ISTA 3A, 3E, 3F General simulation performance tests.
      • ISTA 6-AMAZON.COM, ISTA 6-SAMSCLUB, ISTA 6-FEDEX Member performance tests.
      • ISTA 7D Temperature tests for transport packaging.
      • ISTA 7E Testing standard for thermal transport packaging used in parcel delivery system shipment.
      • ISO 14000 Environmental management systems — Requirements with guidance for use.
      USA
      • ISTA-6-FedEx-A FedEx A Package Testing.
      • ISTA-6-FedEx-B FecEx B Package Compliance Testing.
      • FED-STD-101C Test Procedures For Packaging Materials.

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