• IEC TR 60601-4-1:2017

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

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

    Language(s):  English

    Published date:  22-05-2017

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 DEGREE OF AUTONOMY (DOA)
    5 PROCESS STANDARDS supporting DOA
    6 BASIC SAFETY and ESSENTIAL PERFORMANCE
      related to DOA
    Annex A (informative) - Rationale for defining
            the AUTOMATIC, AUTONOMY and DOA framework
            and the distinction between a MEDICAL
            ROBOT and other MEE or MES
    Annex B (informative) - DOA and relevant terms
            used in MEE standards
    Annex C (informative) - Exemplar methods for
            classifying DEGREE OF AUTONOMY
    Annex D (informative) - Examples of introducing
            DOA to MEE/MES
    Annex E (informative) - PATIENT SAFETY
            characteristics to be taken into account
            during RISK MANAGEMENT for MEE or MES
            employing DOA
    ANNEX F (informative) - PHYSIOLOGIC CLOSED-LOOP
            CONTROL SYSTEM AND DOA
    Annex G (informative) - Examples of distributed
            ESSENTIAL PERFORMANCE
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA).
    This document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on:
    - methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA;
    - considerations of basic safety and essential performance for an MEE and MES with a DOA; and
    - identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and
    - distinguishing between medical robots, and other MEE and MES.
    Unless specified otherwise, this document considers MEE and MES together.
    The manufacturer of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its intended use and does not have unacceptable risk throughout its life-cycle.
    This document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers.
    There are no prerequisites to this document.

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

    Committee TC 62/SC 62A
    Development Note Stability Date: 2020. (05/2017)
    Document Type Technical Report
    Publisher International Electrotechnical Committee
    Status Current

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

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC 60601-2-37:2007+AMD1:2015 CSV Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    IEC 60601-2-10:2012+AMD1:2016 CSV Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators
    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 60601-2-19:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    ISO/TR 24971:2013 Medical devices Guidance on the application of ISO 14971
    IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    ISO 10328:2016 Prosthetics Structural testing of lower-limb prostheses Requirements and test methods
    ISO 22523:2006 External limb prostheses and external orthoses Requirements and test methods
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
    IEC 60050-151:2001 International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices
    IEC TR 62390:2005 Common automation device - Profile guideline
    IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
    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
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    IEC 60601-2-23:2011 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
    IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
    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 80601-2-59:2017 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
    IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    EN 1985 : 1998 WALKING AIDS - GENERAL REQUIREMENTS AND TEST METHODS
    IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
    IEC 60601-2-39:2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT
    IEC 60601-2-31:2008+AMD1:2011 CSV Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
    IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 13482:2014 Robots and robotic devices Safety requirements for personal care robots
    IEC 60601-2-40:2016 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
    EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
    IEC 60601-2-1:2009+AMD1:2014 CSV 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
    IEC 80601-2-30:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    IEC 60601-2-41:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-41: Particular requirementsfor the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
    ISO 80601-2-61:2011 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
    ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    ISO/IEC Guide 71:2014 Guide for addressing accessibility in standards
    IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
    ISO 16201:2006 Technical aids for persons with disability — Environmental control systems for daily living
    IEC TR 61850-90-7:2013 Communication networks and systems for power utility automation - Part 90-7: Object models for power converters in distributed energy resources (DER) systems
    ISO/TR 22411:2008 Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 60947-2:2016 Low-voltage switchgear and controlgear - Part 2: Circuit-breakers
    IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    ISO 22675:2016 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    IEC 60601-2-45:2011+AMD1:2015 CSV Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
    ISO 8373:1994 Manipulating industrial robots — Vocabulary
    IEC 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
    IEC 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
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