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Compliance Standards
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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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.
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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
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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.
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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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