• EN 60601-1-11:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    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 (IEC 60601-1-11:2015)

    Available format(s): 

    Superseded date:  04-08-2021

    Language(s): 

    Published date:  12-01-2013

    Publisher:  European Committee for Standards - Electrical

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 General requirements for testing ME EQUIPMENT
    6 Classification of ME EQUIPMENT and ME SYSTEMS
    7 ME EQUIPMENT identification, marking and documents
    8 Protection against excessive temperatures and other HAZARDS
    9 Accuracy of controls and instruments and protection against
       hazardous outputs
    10 Construction of ME EQUIPMENT
    11 Protection against strangulation or asphyxiation
    12 Additional requirements for ELECTROMAGNETIC EMISSIONS
       of ME EQUIPMENT and ME SYSTEMS
    13 Additional requirements for ALARM SYSTEMS of ME
       EQUIPMENT and ME SYSTEMS
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex C (informative) - Symbols on marking
    Bibliography
    Index of defined terms used in this collateral standard
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Coverage of Essential
             Requirements of EU Directives

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.

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

    Committee TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By

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

    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 60601-1-2:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
    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
    16/30312315 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
    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
    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
    17/30357644 DC : 0 BS EN ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF INTERMITTENT AUTOMATED MEASUREMENT TYPE
    UNE-EN 60601-2-66:2016 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
    BS EN 60601-1-12:2015 (published 2015-06) Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
    BS EN 60601-2-66:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
    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
    CEI EN 60601-1-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    16/30316718 DC : 0 BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    BS EN 62366-1:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    16/30346835 DC : 0 BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
    UNE-EN 80369-5:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
    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 62366-1:2015&AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    CEI EN 60601-2-16 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    I.S. EN 62366-1:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    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
    BS EN 60601-2-37 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT
    I.S. EN 60601-1-12:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
    I.S. EN 60601-2-66:2015 MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
    BS EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    I.S. EN 60601-2-16:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    I.S. EN 60601-1-2:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    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)
    EN 60601-2-66:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS (IEC 60601-2-66:2015)
    BS EN 60601-2-16:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    EN 60601-1-12:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT (IEC 60601-1-12:2014)
    EN 62366-1:2015/AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
    EN 60601-1-2:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS (IEC 60601-1-2:2014)
    EN 60601-2-16:2015 (edition 2) Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    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)
    EN 60601-2-37:2008/A1:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    EN 60601-2-54:2009/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    IEC 60038:2009 IEC standard voltages
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    EN 60065:2014/AC:2017-01 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016)
    EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    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
    MIL STD 810 : G ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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 8124-1:2014 Safety of toys Part 1: Safety aspects related to mechanical and physical properties
    EN 60950-1:2006/A2:2013 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED)
    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
    EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    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
    EN 60721-3-7:1995/A1:1997 CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE
    IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medicaldevices
    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
    EN 60601-1-2:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS (IEC 60601-1-2:2014)
    EN 60068-2-27:2009 ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK
    EN 60601-1-12:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT (IEC 60601-1-12:2014)
    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
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    EN 55011:2016/A1:2017 INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT (CISPR 11:2015/A1:2016)
    EN 61032 : 1998 PROTECTION OF PERSONS AND EQUIPMENT BY ENCLOSURES - PROBES FOR VERIFICATION (IEC 61032:1997)
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    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
    MIL HDBK 310 : 0 DEPARTMENT OF DEFENSE HANDBOOK - GLOBAL CLIMATIC DATA FOR DEVELOPING MILITARY PRODUCTS
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    EN 60335-1:2012/A13:2017 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED)
    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
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 61032:1997 Protection of persons and equipment by enclosures - Probes for verification
    EN 60601-1-9:2008/A1:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007/A1:2013)
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    EN ISO 7010 : 2012 AMD 7 2017 GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016)
    EN 60038 : 2011 CENELEC STANDARD VOLTAGES (IEC 60038:2009, MODIFIED)
    EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
    EN 60068-2-31:2008 ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS
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