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  • IEC 62304:2006+AMD1:2015 CSV

    Current The latest, up-to-date edition.

    Medical device software - Software life cycle processes

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

    Language(s):  English, English - French

    Published date:  26-06-2015

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.

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

    Committee TC 62/SC 62A
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

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    AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
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    NF EN ISO 80601-2-13 : 2013 AMD 1 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
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    I.S. EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
    AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    DIN EN ISO 6875:2011-10 DENTISTRY - PATIENT CHAIR
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    DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
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    ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
    UNE-EN ISO 80601-2-13:2013 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
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    I.S. EN ISO 6875:2011 DENTISTRY - PATIENT CHAIR
    I.S. EN 12182:2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
    I.S. EN 1640:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
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    ANSI/AAMI/IEC 80001-1:2010 APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
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    I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
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    IEEE 11073-10419-2015 IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump
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    EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
    NF EN ISO 80601-2-12 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    I.S. EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    IEC TR 62348:2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
    ISO/TS 20405:2018 Health informatics Framework of event data and reporting definitions for the safety of health software
    ANSI/AAMI/ISO 14708-1:2014 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    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)
    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)
    I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    EN ISO 11073-10425:2016 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016)
    IEEE 11073-10427-2016 IEEE Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices
    CEI EN 80001-1 : 2016 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
    PD IEC/TR 62809:2013 Summary of requirements and tests for products in the scope of IEC 60601-2-66
    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)
    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
    DIN EN ISO 11608-1 E : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
    UNE-EN ISO 6875:2012 Dentistry - Patient chair (ISO 6875:2011)
    DIN EN 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    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
    BS EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods
    ISO 20072:2009 Aerosol drug delivery device design verification Requirements and test methods
    BS EN 13060 : 2014 SMALL STEAM STERILIZERS
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    ISO 6875:2011 Dentistry Patient chair
    BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
    BS EN ISO 6875:2011 Dentistry. Patient chair
    UNE-EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
    UNE-EN 62083:2010 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
    UNI EN ISO 80601-2-13 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
    IEC 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
    ISO/IEEE 11073-20601:2016 Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol
    BS EN 12182:2012 Assistive products for persons with disability. General requirements and test methods
    EN ISO 11073-10419:2016 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
    EN ISO 11073-20601:2016 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016)
    EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
    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)
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
    EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
    EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
    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)
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    EN ISO 11073-10441:2017 Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015)
    EN ISO 6875:2011 Dentistry - Patient chair (ISO 6875:2011)
    ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    PREN 45502-1 : DRAFT 2013 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    15/30246774 DC : 0 BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
    BS EN 62083:2009 Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
    I.S. EN 80001-1:2011 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
    IEEE 11073-10441-2013 Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor
    S.R. CEN TR 15640:2007 HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
    PD CEN/TR 15640:2007 Health informatics. Measures for ensuring the patient safety of health software
    ISO/IEEE 11073-10427:2018 Health informatics — Personal health device communication — Part 10427: Device specialization — Power status monitor of personal health devices
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    NF EN 60601-1-10 : 2008 AMD 1 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
    I.S. EN ISO 11073-10425:2016 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10425: DEVICE SPECIALIZATION - CONTINUOUS GLUCOSE MONITOR (CGM) (ISO 11073-10425:2016)
    EN ISO 11073-10427:2018 Health informatics - Personal health device communication - Part 10427: Device specialization - Power status monitor of personal health devices(ISO/IEEE 11073-10427:2018)
    BS EN ISO 7494-1:2011 Dentistry. Dental units General requirements and test methods
    IEEE 11073-10425-2014 Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM)
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
    IEEE 11073-10418-2011 IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor
    BS IEC 82304-1 : 2016 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
    NF EN ISO 11073-10406 : 2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
    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
    IEEE 11073-20601-2014 REDLINE IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol
    DIN EN ISO 7494-1:2011-11 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
    IEEE 11073-10424-2014 IEEE Standard - Health informatics--Personal health device communication - Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE)
    UNE-EN 13060:2015 Small steam sterilizers
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    I.S. EN ISO 20072:2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
    IEC TR 62809:2013 Summary of requirements and tests to products in the scope of IEC 60601-2-66
    BS EN ISO 80601-2-13:2012+A2:2019 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    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)
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    BS EN 1422:2014 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
    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 ISO 11608-1:2015 Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems
    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 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
    EN 12182:2012 Assistive products for persons with disability - General requirements and test methods
    EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    UNE-EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components

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    ISO 9001:2015 Quality management systems — Requirements
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    ISO 14971:2007 Medical devices Application of risk management to medical devices
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    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - 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
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