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  • IEC 60601-2-19:2009+AMD1:2016 CSV

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

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

    Superseded date:  16-08-2021

    Language(s):  English - French

    Published date:  29-04-2016

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC 60601-2-19:2009+A1:2016 specifies safety requirements for infantincubators. This particular standard amends and supplements IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This second edition cancels and replaces the first edition published in 1990 and its Amendment 1 (1996). This edition constitutes a technical revision. It was revised to structurally align with the third edition (2005) of IEC 60601-1. The contents of the corrigendum of February 2012 have been included in this copy. This consolidated version consists of the second edition (2009) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication.

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    Committee TC 62/SC 62D
    Development Note Stability date: 2020. (05/2016)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

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

    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
    CSA C22.2 No. 80601-2-35 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    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
    AAMI ISO 80601-2-35 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    BS EN ISO 80601-2-56:2017 Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    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
    CSA Z8185 : 2008(R2013) RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    15/30323081 DC : 0 BS EN 80601-2-35 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    BS 5724-2.35(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR BLANKETS, PADS AND MATTRESSES INTENDED FOR HEATING AND MEDICAL USE
    07/30151731 DC : 0 BS IEC 80601-2-35 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
    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
    ISO 80601-2-74:2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
    I.S. EN 80601-2-35:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    EN 60601-2-35:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    I.S. EN ISO 80601-2-56:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
    BS EN 60601-2-21 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009)
    I.S. EN 60601-2-50:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT
    CSA C22.2 No. 60601-2-21 : 2010FR MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    AAMI IEC 60601-2-50 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT
    I.S. EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
    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)
    I.S. EN 60601-2-21:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    EN 60601-2-50:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT (IEC 60601-2-50:2009/A1:2016)
    CSA C22.2 No. 80601-2-35 : 2012(R2016) MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    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
    CSA C22.2 No. 60601-2-21 : 2010 : INC : COR 1 : 2017 : R201400 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    CSA C22.2 No. 80601-2-35 : 2012 : INC : COR 1 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
    IEC 60601-2-21:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    I.S. EN ISO 8185:2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    DIN EN 60601-2-35 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
    04/30088533 DC : DRAFT MARCH 2004 BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    AAMI IEC 60601-2-20 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSPORT INCUBATORS
    BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    EN 80601-2-35:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)
    BS EN 60601-2-50 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT (IEC 60601-2-50:2009)
    I.S. EN 60601-2-20:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    ASTM F 1690 : 1996 : R2004 Standard Specification for Humidifiers for Medical Use—Part 1: General Requirements for Active Humidification Systems (Withdrawn 2013)
    EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    UNI EN ISO 8185 : 2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    BS 5724-2.120(1991) : 1991 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR TRANSPORT INCUBATORS
    CSA C22.2 No. 60601.2.50 : 2010 : INC : COR 1 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    07/30164508 DC : 0 IEC 60601-2-21 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    16/30346835 DC : 0 BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
    CSA C22.2 No. 60601-2-21 : 2010 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
    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
    ASTM F 1690 : 1996 Standard Specification for Humidifiers for Medical Use-Part 1 General Requirements for Active Humidification Systems
    BS EN ISO 8185:2007 Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
    IEC 60601-2-50:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    IEC 60601-2-20:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators
    EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
    BS EN 60601-2-35:1997 Medical electrical equipment. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use
    CSA C22.2 No. 60601.2.50 : 2010 : R2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT
    AAMI IEC 60601-2-21 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    BS EN 80601-2-35 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    CSA Z8185 : 2008 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    CSA C22.2 No. 60601.2.50 : 2010FR MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT
    CSA C22.2 No. 60601-2-21 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    EN ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
    UNE-EN 60601-2-21:2010 Medical electrical equipment -- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
    EN 60601-2-21:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016)
    EN 60601-2-20:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016)
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    DIN EN ISO 8185:2009-07 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS

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

    IEC 60601-2-21:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    IEC 60601-2-50:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment
    ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    IEC 60601-2-20:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators
    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
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