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  • ISO 21647:2004

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors

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

    Withdrawn date:  23-09-2021

    Language(s): 

    Published date:  17-11-2004

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 21647:2004 specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. It supplements the requirements of IEC 60601-1:1988.

    ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring.

    ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents.

    The requirements of ISO 21647:2004 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.

    Environmental aspects are addressed in Annex CC. Additional aspects of environmental impact are addressed in ISO 14971.

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

    Development Note Supersedes ISO/DIS 21647, ISO 7767, ISO 9918 and ISO 11196. (11/2004) Supersedes ASTM F 1452 and ASTM F 1456 (05/2006)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    CSA Z8835.3 : 2008 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    CSA C22.2 No. 60601-2-20 : 2010 : INC : COR 1 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
    06/30154548 DC : DRAFT AUG 2006 EN 60601-2-19 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF BABY INCUBATORS
    DIN EN ISO 8835-3:2011-02 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
    06/30154556 DC : DRAFT AUG 2006 EN 60601-2-20 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSPORT INCUBATORS
    CSA C22.2 No. 60601.2.13 : 2007 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    I.S. EN ISO 81060-1:2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)
    CSA C22.2 No. 80601-2-55 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
    AAMI IEC 80601-2-30 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    BS ISO 81060-1 : 2007 COR 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
    06/30137313 DC : 0 ISO/IEC 81060-1 - NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR MECHANICAL TYPE
    DIN EN ISO 81060-1:2012-08 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
    CSA C22.2 NO. 60601-2-20:10 (R2019) Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (Adopted IEC 60601-2-20:2009, second edition, 2009-02) | Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés (norme CEI 60601-2-20:2009 adoptée, deuxième édition, 2009-02)
    UNE-EN 60601-2-20:2010 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
    UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    CSA C22.2 No. 60601-2-20 : 2010FR MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
    IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
    DIN EN ISO 10651-2:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    UNI EN ISO 81060-1 : 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
    NF EN ISO 8835-3 : 2009 AMD 1 2011 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    09/30197590 DC : 0 BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    14/30289772 DC : 0 BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    BS EN ISO 81060-1:2012 Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type
    AAMI ISO 81060-1:2007(R2013) NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
    CSA C22.2 No. 80601-2-30 : 2010 : INC : COR 1 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    CSA C22.2 No. 80601-2-30 : 2010FR MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    CSA C22.2 No. 80601-2-30 : 2010 : R2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    I.S. EN 80601-2-30:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    CSA C22.2 No. 60601.2.13 :2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    ISO 23552-1:2007 Safety and control devices for gas and/or oil burners and gas and/or oil appliances — Particular requirements — Part 1: Fuel/air ratio controls, electronic type
    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
    UNI EN ISO 10651-2 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS
    AAMI ISO 81060-1 : 2007 NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
    PREN ISO 80601-2-55 : DRAFT 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    UNI EN ISO 8835-3 : 2010 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    CSA Z10651.2: 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    UNI EN ISO 80601-2-55 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    CSA C22.2 No. 60601-2-20 : 2010(R2014) MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
    I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
    BS EN ISO 10651-2:2004 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients
    DIN EN 13976-2 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
    IEC 80601-2-30:2018 RLV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    EN ISO 8835-3:2009/A1:2010 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    06/30159274 DC : 0 BS EN 80601-2-30 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED TYPE NON-INVASIVE SPHYGMOMANOMETERS
    BS EN ISO 8835-3 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    I.S. EN ISO 10651-2:2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    BS EN 60601-2-20 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
    BS EN 80601-2-30 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    IEC 80601-2-30 REDLINE : 2ED 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    CSA Z10651.2 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    I.S. EN ISO 8835-3:2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    DIN EN 13976-2:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
    EN 80601-2-30:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013)
    DIN EN 13976-2:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS

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

    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 12598 : 1999 OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS
    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
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    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 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    EN 864 : 1996 MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS
    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/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
    IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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