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  • ISO 10651-6:2004

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  12-03-2019

    Language(s):  English, French

    Published date:  28-06-2004

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 10651-6:2004 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in hospitals) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. It is intended to be used in conjunction with the General Standard IEC 60601-1:1988.

    The requirements of ISO 10651-6:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 10651-6. (07/2004) 2004 version partially supersedes ISO 10651-2:1996 (11/2004)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    CAN/CSA-C22.2 NO. 80601-2-72:17 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
    CSA Z17510.1 : 2010 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    BS EN ISO 80601-2-12:2011 Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators
    17/30338753 DC : 0 BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT
    BS EN ISO 80601-2-72:2015 Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
    UNI EN ISO 80601-2-12 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    CSA C22.2 No. 80601-2-12 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    DIN EN ISO 17510-1:2009-07 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
    I.S. EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
    15/30300279 DC : 0 BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
    DIN EN ISO 80601-2-72 E : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
    16/30295446 DC : 0 BS ISO 19223 - LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS
    I.S. EN ISO 80601-2-12:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
    CSA C22.2 No. 80601-2-12 : 2012(R2017) MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    17/30338756 DC : 0 BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY
    13/30264413 DC : 0 BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    I.S. EN ISO 80601-2-72:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
    UNI EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    ISO 80601-2-70:2015 Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
    EN ISO 80601-2-12:2011/AC:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
    ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    BS EN ISO 17510-1:2009 Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment
    ISO 80601-2-72:2015 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    EN ISO 80601-2-72:2015 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
    CAN/CSA-C22.2 NO. 80601-2-70:17 Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations)
    13/30254355 DC : 0 BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT
    ISO 17510-1:2007 Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements
    ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    ISO 10241:1992 International terminology standards Preparation and layout
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 14937:2009 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
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
    IEC 60601-1-8:2006+AMD1:2012 CSV 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
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 5362:2006 Anaesthetic reservoir bags
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 13014:2000/AC:2002 CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
    ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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