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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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