IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV
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Information technology equipment - Safety - Part 1: General requirements
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CSA C22.2 No. 60601-1-11 : 2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
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IEC 60038:2009
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IEC standard voltages
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ISO 8836:2014
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Suction catheters for use in the respiratory tract
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ISO 7010:2011
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Graphical symbols Safety colours and safety signs Registered safety signs
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ISO 4871:1996
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Acoustics — Declaration and verification of noise emission values of machinery and equipment
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ISO 3744:2010
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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
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ISO 80601-2-13:2011
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Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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Z7396.1-17
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Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems
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EN 15986:2011
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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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EN 13718-1:2014
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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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ISO 10651-2:2004
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Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
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ISO 10651-6:2004
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Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
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CFR 45(PTS1-199) : OCT 2017
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PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
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IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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IEC 60721-3-7:1995+AMD1:1996 CSV
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Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
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ISO 5356-1:2015
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Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
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ISO 10651-4:2002
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Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
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ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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ISO 80601-2-70:2015
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Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
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IEC 60601-1-8:2006+AMD1:2012 CSV
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Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
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ISO 5356-2:2012
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Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
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IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices
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ISO 32:1977
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Gas cylinders for medical use — Marking for identification of content
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ISO 5367:2014
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Anaesthetic and respiratory equipment — Breathing sets and connectors
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IEC 60601-1-2:2014
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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ISO 10651-3:1997
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Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
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ISO 8185:2007
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Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
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ISO/TR 16142:2006
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Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes
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ISO 14159:2002
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Safety of machinery — Hygiene requirements for the design of machinery
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ISO 23328-2:2002
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Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
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IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice
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ASTM F 2761 : 2009 : R2013
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Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
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IEC 60601-1-3:2008+AMD1:2013 CSV
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Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
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ISO 80369-1:2010
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Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
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ISO 80601-2-55:2011
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Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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ISO 17510:2015
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Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
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ISO 23328-1:2003
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Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
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CSA Z5359 : 2016
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
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ISO 9360-1:2000
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Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
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EN 1789:2007+A2:2014
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Medical vehicles and their equipment - Road ambulances
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 7000:2014
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Graphical symbols for use on equipment Registered symbols
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ISO 4135:2001
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Anaesthetic and respiratory equipment Vocabulary
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ISO 9360-2:2001
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Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
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ISO 10524-1:2006
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Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
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IEC 60601-2-12:2001
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Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
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ISO 594-2:1998
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Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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ISO 11195:1995
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Gas mixers for medical use Stand-alone gas mixers
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ISO 594-1:1986
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Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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