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  • IEC 60601-1-4:1996+AMD1:1999 CSV

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    Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  31-12-2021

    Language(s):  English - French

    Published date:  07-04-2000

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    SECTION 1: GENERAL
    1 Scope, object and relationship to other standards
       1.201 Scope
       1.202 Object
       1.203 Relationship to other standards
    2 Terminology and definitions
       2.201 Defined terms
       2.202 Degrees of requirements and miscellaneous terms
    6 Identification, marking and documents
       6.8 ACCOMPANYING DOCUMENTS
    SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL
               TESTS
    52 Abnormal operation and fault conditions
       52.201 Documentation
       52.202 RISK management plan
       52.203 DEVELOPMENT LIFE-CYCLE
       52.204 RISK management process
       52.205 Qualification of personnel
       52.206 Requirement specification
       52.207 Architecture
       52.208 Design and implementation
       52.209 VERIFICATION
       52.210 VALIDATION
       52.211 Modification
       52.212 Assessment
    Annexes
    AAA - Terminology - Index of defined terms
    BBB - Rationale
    CCC - RISK concepts
    DDD - DEVELOPMENT LIFE-CYCLE
    EEE - Examples for PEMS/PESS structures
    FFF - Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents. This consolidated version consists of the first edition (1996) and its amendment 1 (1999). Therefore, no need to order amendment in addition to this publication.

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    Committee TC 62
    Development Note Also Numbered as BS EN 60601-1.4 & IEC 60601-1-4. (03/2001) Stability Date: 2013. (10/2012)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Withdrawn

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

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    04/30089749 DC : DRAFT DEC 2004 BS EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
    I.S. EN ISO 22523:2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
    03/103294 DC : DRAFT JAN 2003 BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
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    UNE-EN 60645-6:2010 Electroacoustics - Audiometric equipment -- Part 6: Instruments for the measurement of otoacoustic emissions
    03/311987 DC : DRAFT AUG 2003 BS EN 60601-2-27 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
    AAMI ID26:2004 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
    CSA Z10651.6 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    AAMI DF80 : 2003 : R2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS]
    AAMI ISO TIR 16142 : 2005 MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES
    CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA Z9919 : 2007 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    CSA C22.2 No. 60601.2.12 : 2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    CSA C22.2 No. 60601.1.1 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    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
    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
    CSA C22.2 No. 60601.1.1 : 2002 : R2006 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    CSA C22.2 No. 60601.2.51 : 2004 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
    AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    BS EN ISO 80601-2-13:2012+A2:2019 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
    ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
    BS EN ISO 22523:2006 External limb prostheses and external orthoses. Requirements and test methods
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    EN ISO 80601-2-13:2012 (edition 2) Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
    EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
    EN 60601-2-51 : 2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
    EN 60645-5:2005 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE
    CEN/TS 15260:2006 HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS
    DIN EN 60601-2-30 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
    BS EN ISO 80601-2-13:2012 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    BS EN 60601-2-38 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-38: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
    BS EN 60645-6:2010 Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions
    DD ISO/TS 25238 : 2007 HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH SOFTWARE
    14/30315340 DC : 0 BS EN 60601-2-66 ED.2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
    14/30287753 DC : 0 BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
    BS ISO 15378 : 2006 AMD 17315 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
    BS EN 60601-2-12 : 2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    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
    02/564924 DC : DRAFT NOV 2002 ISO 21647 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    07/30173580 DC : 0 BS EN 60645-6 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
    ANSI Z80.11:2012 OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
    AAMI TIR32 : 2004 : R2016 MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
    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 5724-2.38(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
    CEI EN 60645-1 : 2016 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AUDIOMETRY
    CEI EN 62274 : 2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
    PD 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 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
    CSA ISO/IEC TR 15942:2004 INFORMATION TECHNOLOGY - PROGRAMMING LANGUAGES - GUIDE FOR THE USE OF THE ADA PROGRAMMING LANGUAGE IN HIGH INTEGRITY SYSTEMS
    UNI EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    I.S. EN 60645-6:2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
    BIS IS/ISO 14708-1 : 2000 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
    CSA C22.2 No. 601.2.20 : 1992 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF TRANSPORT INCUBATORS
    CSA C22.2 No. 601.1.1 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    CSA C22.2 No. 601.2.29 : 0 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY SIMULATORS
    AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    DIN EN ISO 6875:2011-10 DENTISTRY - PATIENT CHAIR
    DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
    DIN EN ISO 17510-1:2009-07 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    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)
    BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
    BS EN 1441:1998 MEDICAL DEVICES - RISK ANALYSIS
    DIN EN ISO 11608-4:2016-03 (Draft) PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
    I.S. EN ISO 6875:2011 DENTISTRY - PATIENT CHAIR
    I.S. EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    I.S. EN 1640:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
    I.S. EN ISO 10651-6:2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    DIN EN ISO 10651-2:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    CSA C22.2 No. 60601.1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    I.S. EN ISO 9919:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    AAMI IEC TIR 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
    AAMI TIR72 : 2017 DIALYSIS FLUID CHEMICAL COMPOSITION
    11/30243761 DC : 0 BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
    BS ISO/IEC TR 15942 : 2000
    UNE-EN 62304:2007 Medical device software - Software life-cycle processes (IEC 62304:2006)
    CSA ISO/IEC TR 15942 : 2004 : R2014 INFORMATION TECHNOLOGY - PROGRAMMING LANGUAGES - GUIDE FOR THE USE OF THE ADA PROGRAMMING LANGUAGE IN HIGH INTEGRITY SYSTEMS
    02/564070 DC : DRAFT SEP 2002 BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
    07/30136476 DC : DRAFT APR 2007 IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    BS EN 60601-1-1:2001 Medical electrical equipment. General requirements for safety Collateral standard. Safety requirements for medical electrical systems
    07/30173584 DC : 0 BS EN 60645-7 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY EVOKED POTENTIALS
    AAMI DF80:2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS]
    AAMI ID26 : 2004 : R2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
    CSA Z10651.6 : 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    CSA Z9919 :2007 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    AAMI IEC 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
    CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    UNE-EN ISO 7494-1:2012 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
    I.S. EN 60601-1-1:2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    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
    I.S. EN ISO 80601-2-13:2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011)
    CSA C22.2 No. 601.2.19 : 1992 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF BABY INCUBATORS
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    ISO 14971:2007 Medical devices Application of risk management to medical devices
    BS EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    I.S. EN 60645-5:2005 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE
    I.S. EN 62304:2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
    DIN EN ISO 10651-6:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
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    IEC 60645-6:2009 Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
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    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
    IEC 60645-5:2004 Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance
    UNI EN ISO 6875 : 2011 DENTISTRY - PATIENT CHAIR
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    I.S. EN ISO 11608-4:2007 PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
    EN ISO 9919:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    UNI EN ISO 9919 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    UNI EN ISO 10651-6 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    PD ISO/TR 27809:2007 Health informatics. Measures for ensuring patient safety of health software
    I.S. EN 62274:2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
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    ISO/TS 25238:2007 Health informatics Classification of safety risks from health software
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    08/30176438 DC : DRAFT JAN 2008 BS EN 60645-1 - ELECTRO ACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: PURE-TONE AUDIOMETERS
    BS PD IEC TR 60788 : 2004 MEDICAL ELECTRICAL EQUIPMENT - GLOSSARY OF DEFINED TERMS
    BS 5724-2.44(1999) : 1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    BS EN 62274 : 2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
    CSA C22.2 No. 60601.1.1 : 2002 : R2011 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    BS EN ISO 11073-00103 : 2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    NF EN 60645-6 : 2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
    CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    BS 5724-2.18(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT
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    03/103293 DC : DRAFT JAN 2003 BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
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    01/561640 DC : DRAFT APR 2001 BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES
    DD CEN/TS 15260 : 2006 HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS
    CSA Z10651.2 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    CSA Z10651.2: 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    ANSI Z80.11 : 2012 : R2017 OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
    AAMI TIR32 :2004 MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
    EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    CEI EN 60601-1-1 : 2003 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    I.S. CEN TS 15260:2006 HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS
    AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA Z8835.5 : 2006 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS
    IEEE 730 : 2014 SOFTWARE QUALITY ASSURANCE PROCESSES
    I.S. EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    CSA CEI/IEC 62304:14 (R2019) Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05)
    UNI EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    BS EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    I.S. EN 60601-2-38:1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
    DIN EN ISO 8835-5:2009-07 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS
    UNE-EN ISO 6875:2012 Dentistry - Patient chair (ISO 6875:2011)
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    BS EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
    BS EN ISO 10651-6 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    BS EN ISO 11608-4:2007 Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors
    ISO 11608-4:2006 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 6875:2011 Dentistry Patient chair
    BS EN 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
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    BS EN ISO 6875 : 2011 DENTISTRY - PATIENT CHAIR
    ISO 22523:2006 External limb prostheses and external orthoses Requirements and test methods
    IEC 60601-2-30:1999 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    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
    EN ISO 11073-00103 : 2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    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 ISO 10651-6:2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    EN ISO 8835-5:2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    EN ISO 11608-4:2007 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
    EN ISO 6875:2011 DENTISTRY - PATIENT CHAIR
    BS 5724-2.39(1999) : 1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR PERITONEAL DIALYSIS EQUIPMENT
    I.S. EN ISO 8835-5:2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS
    I.S. 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
    BS ISO 27427:2013 Anaesthetic and respiratory equipment. Nebulizing systems and components
    14/30287226 DC : 0 BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
    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
    00/560888 DC : APR 2000 IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
    AAMI RD5 : 2003 HEMODIALYSIS SYSTEMS
    04/30079743 DC : DRAFT APR 2004 ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
    03/111613 DC : DRAFT AUG 2003 BS EN ISO 9919 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    CSA Z10651.6 :2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    AAMI ID26 : 2004 : R2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
    CSA Z17510.1 : 2010 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    07/30166162 DC : 0 BS IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    I.S. EN 60601-2-30:2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
    CEI 62-143 : 2007 MAPPING BETWEEN THE CLAUSES OF THE THIRD EDITION OF IEC 60601-1 AND THE 1988 EDITION AS AMENDED
    BS EN 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    CEI 65-186 : 2010 GUIDELINE ON THE APPLICATION OF THE STANDARD SERIES CEI EN 61511 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR
    CSA ISO/IEC TR 15942:04 (R2019) Information Technology - Programming Languages - Guide for the Use of the Ada Programming Language in High Integrity Systems (Adopted ISO/IEC TR 15942:2000, first edition, 2000-03-01)
    DIN EN ISO 7494-1:2011-11 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
    EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    ISO 27427:2013 Anaesthetic and respiratory equipment Nebulizing systems and components
    I.S. EN 60601-2-51:2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    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)
    ISO 17510-1:2007 Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment
    BS EN ISO 8835-5 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS
    IEC 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 62274 : 2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
    EN 60601-2-38:1996/A1:2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
    EN 60601-2-30:2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
    EN 60601-2-12 : 2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    EN 60645-6 : 2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS

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

    IEC 61025:2006 Fault tree analysis (FTA)
    ISO/IEC 15026:1998 Information technology System and software integrity levels
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    IEC 61508-5:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508)
    IEC 61508-4:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (see Functional Safety and IEC 61508)
    IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    ISO/IEC 12119:1994 Information technology Software packages Quality requirements and testing
    IEC 60880:2006 Nuclear power plants - Instrumentation and control systems important to safety - Software aspects for computer-based systems performing category A functions
    IEC 61508-6:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (see Functional Safety and IEC 61508)
    IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
    IEC 61508-7:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures (see Functional Safety and IEC 61508)
    IEC 61508-2:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems (see Functional Safety and IEC 61508)
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