• IEC 60601-1-8:2006+AMD1:2012 CSV

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems

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

    Superseded date:  25-07-2020

    Language(s):  English - French

    Published date:  28-11-2012

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION TO THE AMENDMENT
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 ME EQUIPMENT identification marking and documents
    6 ALARM 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 (normative) - Symbols on marking
    ANNEX D (informative) - Guidance for auditory ALARM SIGNALS
    ANNEX E (informative) - Verbal ALARM SIGNALS
    ANNEX F (normative) - Reserved melodies for ALARM SIGNALS
    Bibliography
    Index of defined terms used in this collateral standard

    Abstract - (Show below) - (Hide below)

    IEC 60601-1-8:2006+A1:2012 Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems. This consolidated version consists of the second edition (2006) and its amendment 1 (2012). Therefore, no need to order amendment in addition to this publication.

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

    Committee TC 62/SC 62A
    Development Note Supersedes ASTM F 1463 (04/2006) Stability Date: 2019. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Supersedes

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

    CSA C22.2 No. 80601-2-56 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
    AAMI IEC TIR 60878 : 2003 GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE
    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
    BS PD IEC TR 60601-4-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 4-2: GUIDANCE AND INTERPRETATION - ELECTROMAGNETIC IMMUNITY: PERFORMANCE OF MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    PD IEC/TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    CEI 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
    PD IEC/TR 62366-2:2016 (published 2016-04) Medical devices Guidance on the application of usability engineering to medical devices
    AAMI ISO 80601-2-35 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    PREN ISO 80601-2-61 : DRAFT 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    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
    BS ISO 11197 : 2016 MEDICAL SUPPLY UNITS
    15/30300279 DC : 0 BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
    BS EN ISO 80601-2-69:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
    CSA Z8185 : 2008 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    15/30323081 DC : 0 BS EN 80601-2-35 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    CSA ISO 26722 : 2016 WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES
    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
    13/30242951 DC : 0 BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
    CEI EN 60601-2-23 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT
    EN IEC 60601-2-2 : 2018 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 60601-2-2:2017)
    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
    DIN EN ISO 80601-2-69 E : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014)
    09/30191860 DC : 0 BS EN 60601-1-6 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - USABILITY
    15/30312454 DC : 0 BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
    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
    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
    CSA Z8185 : 2008(R2013) RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    IEC 80601-2-49:2018 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    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 ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    ISO 11197:2016 Medical supply units
    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. 60601.2.49 : 2011 : R2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT
    UNE-EN ISO 80601-2-69:2015 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
    CAN/CSA-C22.2 NO. 80601-2-72:17 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
    AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    ISO 16142-1:2016 Medical devices Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    I.S. EN 60601-2-29:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS (IEC 60601-2-29:2008 (EQV))
    BS EN ISO 7396-1:2016 (published 2016-03) Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
    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
    I.S. EN 60601-2-24:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    AAMI IEC 60601-2-27:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
    BS 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/IEC 80601-2-12:2011)
    BS EN 60601-1-6 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
    BS EN ISO 80601-2-61:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    ISO 80601-2-74:2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
    I.S. EN 80601-2-35:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    IEC TR 60930:2008 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
    ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    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
    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)
    ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
    NF 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
    IEC 60601-2-46:2016 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
    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 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 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    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 60601-2-34:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (IEC 60601-2-34:2011)
    EN ISO 21647:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    12/30159217 DC : 0 BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
    BS EN ISO 80601-2-13:2012 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    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
    BS EN ISO 80601-2-72:2015 Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    BS EN ISO 26722 : 2015 WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES
    CEI EN 60601-2-24 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    AAMI IEC 60601-2-27 : 2011 : R2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
    16/30329598 DC : 0 BS ISO 11195 - GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS
    DIN EN ISO 80601-2-72:2016-04 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)
    AAMI IEC TIR 80001-2-2 : 2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS
    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)
    AAMI IEC 80601-2-30 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    03/114562 DC : DRAFT SEP 2003 BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
    AAMI TIR66 : 2017 GUIDANCE FOR THE CREATION OF PHYSIOLOGIC DATA AND WAVEFORM DATABASES TO DEMONSTRATE REASONABLE ASSURANCE OF THE SAFETY AND EFFECTIVENESS OF ALARM SYSTEM ALGORITHMS
    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
    14/30303965 DC : 0 BS EN 60601-2-33/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    UNI EN ISO 80601-2-12 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
    12/30271196 DC : 0 BS EN 60601-1-10:2007/A1 - 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
    03/111582 DC : DRAFT JULY 2003 BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
    06/30160368 DC : 0 BS EN 80100 - BASIC SAFETY AND ESSENTIAL PERFORMANCE REQUIREMENTS OF CLINICAL THERMOMETER FOR BODY TEMPERATURE MEASUREMENT
    BS PD IEC TR 60601-4-4 : 2017 MEDICAL ELECTRICAL EQUIPMENT - PART 4-4: GUIDANCE AND INTERPRETATION - GUIDANCE FOR WRITERS OF PARTICULAR STANDARDS WHEN CREATING ALARM SYSTEM-RELATED REQUIREMENTS
    I.S. EN IEC 60601-2-2:2018 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
    09/30181956 DC : DRAFT MAY 2009 BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    NF 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
    CSA Z21647 : 2007 : R2012 : FR MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    I.S. EN 62366-1:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    I.S. EN ISO 7396-1:2016 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
    BS EN 60601-2-23:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
    IEC 60601-2-46 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES
    UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
    I.S. EN 62366-1:2015&AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    CEI EN 60601-2-27 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
    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)
    I.S. EN 60601-2-2:2009 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 60601-2-2:2009 (EQV))
    AAMI IEC 60601-2-16 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT
    UNI EN ISO 80601-2-55 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    CSA IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    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
    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
    CSA C22.2 No. 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
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    CSA C22.2 No. 60601-1-10 : 2009 : R2014 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
    CSA C22.2 No. 60601.2.2:2009 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
    AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    NF EN 60601-1-12 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
    CSA C22.2 No. 60601-1-10:2009 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
    AAMI IEC TIR 80001-2-5 : 2014 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
    IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    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
    AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    DIN EN ISO 18779 E : 2005 MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
    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)
    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
    EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    I.S. EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    I.S. EN ISO 8185:2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    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
    I.S. EN 60601-2-33:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
    VDE 0750-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
    DIN EN 60601-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
    BS EN 60601-2-2 : 2009 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
    ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
    09/30197590 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
    07/30151731 DC : 0 BS IEC 80601-2-35 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
    14/30296572 DC : 0 BS EN 60601-1-11 - 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 ISO 9919:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    CSA C22.2 No. 60601.2.23 :2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT
    DIN EN ISO 80601-2-72 E : 2016 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)
    16/30319034 DC : 0 BS EN 60601-2-2 ED 6.0 - 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
    13/30268519 DC : 0 BS ISO 80601-2-13:2011/AMD 1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
    13/30270477 DC : 0 BS ISO 26722 - WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES
    UNI EN ISO 80601-2-69 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
    ISO 16571:2014 Systems for evacuation of plume generated by medical devices
    13/30255929 DC : 0 BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
    BS ISO 27427:2013 Anaesthetic and respiratory equipment. Nebulizing systems and components
    04/30088533 DC : DRAFT MARCH 2004 BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    BS ISO 16142-1:2016 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    16/30295446 DC : 0 BS ISO 19223 - LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS
    NF EN 60601-1 : 2007-01 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    16/30349981 DC : 0 BS EN 80601-2-59 ED 2.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
    AAMI IEC 62366 : 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    CSA IEC 62366 : 2014 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    07/30144241 DC : 0 BS IEC 60601-2-29 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS
    UNI EN ISO 20072 : 2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
    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
    CSA C22.2 No. 60601.2.29 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS
    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
    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
    UNE-EN ISO 80601-2-56:2013 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
    BS 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
    AAMI HE75 : 2009 HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    EN 80601-2-35:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)
    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
    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
    AAMI ISO 14708-5 : 2010 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
    BS EN 62366 : 2008 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    DIN EN ISO 7396-1:2016-09 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
    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)
    BS PD IEC TR 60601-4-3 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 4-3: GUIDANCE AND INTERPRETATION - CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS IN THE THIRD EDITION OF IEC 60601-1 AND PROPOSALS FOR NEW REQUIREMENTS
    EN ISO 80601-2-61:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    NF EN ISO 80601-2-61 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    EN ISO 80601-2-55:2018 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 80601-2-55:2018 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    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
    BS EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    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
    BS EN ISO 9919 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    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
    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
    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 80601-2-69:2014 Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
    04/30106146 DC : DRAFT MARCH 2004 BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    UNE-EN 60601-2-54:2010 Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    EN ISO 80601-2-69:2014 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
    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 ISO 8185:2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    UNI EN ISO 21647 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    UNI 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
    UNI EN ISO 8835-5 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS
    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
    UNI EN ISO 8185 : 2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    AAMI HA60601-1-11 : 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
    DIN EN ISO 20072:2013-10 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
    12/30258857 DC : 0 BS EN 60601-1-6/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
    BS EN ISO 20072:2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
    14/30244508 DC : 0 BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    14/30281087 DC : 0 BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT
    08/30192448 DC : DRAFT DEC 2008 BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
    06/30147232 DC : DRAFT OCT 2006 IEC 60601-1-10 - 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 21647:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    14/30302072 DC : 0 BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT
    BS ISO 26722 : 2014 WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES
    13/30264413 DC : 0 BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    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
    CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    18/30356489 DC : DRAFT APR 2018 BS EN 60601-1-10:2008 AMENDMENT 2 - 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
    CSA C22.2 No. 60601.2.2 : 2009(R2014) 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
    12/30245174 DC : 0 BS EN 60601-1-12 - 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
    PREN ISO 11197 : DRAFT 2012 MEDICAL SUPPLY UNITS (ISO/DIS 11197:2012)
    PD IEC/TR 80001-2-2:2012 (published 2012-07) Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
    08/30176368 DC : 0 BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    CSA C22.2 No. 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
    I.S. EN 60601-2-27:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
    BS ISO 18190:2016 (published 2016-10) Anaesthetic and respiratory equipment. General requirements for airways and related equipment
    IEC TR 60601-4-2:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
    BS EN 60601-2-24:2015 (published 2015-06) Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    ONORM EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    09/30155521 DC : 0 BS EN 60601-1-11 ED.1 - 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
    CAN/CSA-C22.2 NO. 80601-2-70:17 Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations)
    14/30290166 DC : 0 BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    AAMI 26722 : 2014 WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS AND RELATED THERAPIES
    BS EN 60601-1-2:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
    PREN ISO 80601-2-55 : DRAFT 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    NF EN 60601-2-2 : 2009 AMD 11 2012 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
    17/30341818 DC : 0 BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    07/30145258 DC : 0 BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - 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
    CSA C22.2 No. 60601.2.49:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT
    CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA Z21647:2007 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    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
    CSA Z21647 : 2007 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    I.S. 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
    ISO 80601-2-67:2014 Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
    CSA C22.2 No. 80601-2-55 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    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
    CSA C22.2 No. 60601.2.16 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    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
    CAN/CSA-C22.2 NO. 80601-2-67:17 Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations)
    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 60601-2-49:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT
    I.S. EN ISO 26722:2015 WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014)
    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)
    NF ISO 18190 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
    ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
    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 11197:2016 Medical supply units (ISO 11197:2016)
    UNI EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    CSA C22.2 No. 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
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    00/565497 DC : DRAFT DEC 2000 BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE
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    04/30088537 DC : DRAFT SEP 2004 PREN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
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    09/30203808 DC : 0