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  • EN 62366 : 2008 AMD 1 2015

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)

    Available format(s): 

    Superseded date:  01-12-2015

    Language(s): 

    Published date:  18-12-2015

    Publisher:  European Committee for Standards - Electrical

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definition
    4 Principals
    5 USABILITY ENGINEERING PROCESS
    6 ACCOMPANYING DOCUMENT
    7 Training and materials for training
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Categories of USER action
    Annex C (informative) - Examples of USE ERRORS,
            ABNORMAL USE and possible causes
    Annex D (informative) - Guidance on the USABILITY
            ENGINEERING PROCESS
    Annex E (informative) - Questions that can be
            used to identify MEDICAL DEVICE characteristics
            associated with USABILITY that could impact on SAFETY
    Annex F (informative) - Examples of possible USABILITY
            related HAZARDOUS SITUATIONS
    Annex G (informative) - USABILITY goals: Illustrative
            example for a home parenteral infusion pump
    Annex H (informative) - Sample USABILITY SPECIFICATION
            and its inputs
    Annex I (informative) - Recommended reading list
    Annex J (informative) - Reference to the essential principles
    Annex K (normative) - Evaluation of a USER INTERFACE OF
            UNKNOWN PROVENANCE (UOUP)
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential
             Requirements of EC Directives
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE.

    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)

    CEI EN 60601-1-11 : 2016 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
    I.S. EN 60601-1-6:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
    09/30192045 DC : 0 BS EN 13544-3:2001/A1 - RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    I.S. EN 60601-1-10:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
    09/30192042 DC : 0 BS EN 13544-2:2002/A1 - RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    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 60601-1-6 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
    17/30358658 DC : 0 BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
    I.S. EN 1865-2:2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    BS EN 1782 : 1998 TRACHEAL TUBES AND CONNECTORS
    BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
    ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
    BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    BS EN 13544-3 : 2001 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    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 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    I.S. EN 1865-3:2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
    PREN 13795-1 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
    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 60601-2-66:2015 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
    EN 60601-1-10:2008/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007)
    BS EN 60601-1-8 : 2007 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)
    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)
    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 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
    DIN EN 1782:2009-12 TRACHEAL TUBES AND CONNECTORS
    DIN EN 13544-3:2010-01 Respiratory therapy equipment - Part 3: Air entrainment devices (includes Amendment A1:2009)
    DIN EN 13544-2:2010-01 Respiratory therapy equipment - Part 2: Tubing and connectors (includes Amendment A1:2009)
    BS EN 45502-1:2015 Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer
    I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
    I.S. EN 13544-3:2001 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    I.S. EN 13544-2:2002 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    I.S. EN 794-3:1998 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    I.S. EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    VDI 5702 Blatt 1:2017-04 Medical device software - Medical SPICE Process assessment model
    I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    13/30260084 DC : 0 BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
    DIN EN 1865-2:2015-05 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
    BS EN 60601-1-10 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
    UNE-EN 60601-1-6:2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    BS EN 60601-2-49:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    BS EN 1865-2 : 2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
    I.S. EN 60601-1-8:2007 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
    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
    EN 60601-2-1:2015 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    DIN EN 13544-1:2009-12 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 60601-2-16:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    UNE-EN 1782:1998 TRACHEAL TUBES AND CONNECTORS.
    EN 1782:1998+A1:2009 Tracheal tubes and connectors
    UNI EN 13544-3 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    UNI EN 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    UNI EN 12342 : 2009 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    UNI EN 13544-2 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    UNI EN 794-3 : 2009 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    UNI EN 1782 : 2009 TRACHEAL TUBES AND CONNECTORS
    13/30233325 DC : 0 BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    09/30189968 DC : DRAFT JAN 2009 BS EN 13544-1 AMD1 - RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
    DIN EN 1865-3:2015-05 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
    CEI EN 62083 : 2011 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
    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
    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)
    I.S. EN 60601-1-11:2015 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
    BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    UNE-EN 13544-3:2001 Respiratory therapy equipment - Part 3: Air entrainment devices.
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    UNE-EN 60601-2-49:2016 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
    BS EN 794-3 : 1999 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    UNE-EN 62083:2010 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
    EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
    EN 1865-2:2010+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
    EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
    EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
    EN 1865-3:2012+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
    EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
    09/30192039 DC : DRAFT JAN 2009 BS EN 794-3 AMD2 - LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    BS EN 1865-3 : 2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
    BS EN 60601-1-11:2015 Medical electrical equipment 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
    PREN 45502-1 : DRAFT 2013 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    UNE-EN 60601-2-1:2017 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    BS EN 62083:2009 Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
    BS EN 60601-2-1:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    EN 60601-1-11:2015 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
    IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
    UNE-EN 1865-2:2011 Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
    DIN EN 794-3:2009-12 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
    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 13544-2 : 2002 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    EN 13544-3:2001+A1:2009 Respiratory therapy equipment - Part 3: Air entrainment devices
    EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
    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 60601-2-49:2015 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    UNE-EN 1865-3:2012 Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
    UNE-EN 13544-2:2003 Respiratory therapy equipment - Part 2: Tubing and connectors.
    UNE-EN 794-3:1999 LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS.
    UNE-EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components

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

    ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
    AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    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 9001:2015 Quality management systems — Requirements
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
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