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  • IEC 62366:2007+AMD1:2014 CSV

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    Medical devices - Application of usability engineering to medicaldevices

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

    Superseded date:  12-09-2022

    Language(s):  English - French

    Published date:  28-01-2014

    Publisher:  International Electrotechnical Committee

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

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

    Abstract - (Show below) - (Hide below)

    IEC 62366:2007+A1:2014 Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.This consolidated version consists of the first edition (2007) and its amendment 1 (2014). Therefore, no need to order amendment in addition to this publication.

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    Committee TC 62/SC 62A
    Development Note Stability Date: 2014. (01/2014) Superseded by IEC 62366-1, but remains current and will be withdrawn on publication of IEC 62366-2. (07/2015)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded

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

    DIN EN ISO 10524-4:2008-09 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
    CSA C22.2 No. 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
    I.S. EN ISO 80369-1:2010 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
    NF 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 14708-1:2014 Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    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
    CSA ISO 15197 : 2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    CSA ISO 5361 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    14/30270462 DC : 0 BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
    AAMI ISO 80369-3 : 2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS
    NF EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    BS EN ISO 5840-2:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
    14/30298693 DC : 0 BS ISO 18250-8 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 8: CITRATE-BASED ANTICOAGULANT SOLUTION FOR APHERESIS APPLICATIONS
    UNI EN ISO 23908 : 2013 SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING
    PD IEC/TR 62366-2:2016 (published 2016-04) Medical devices Guidance on the application of usability engineering to medical devices
    AAMI ISO 80369-1 : 2010 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
    PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
    UNI EN ISO 18113-5 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF- TESTING
    09/30203808 DC : 0 BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    17/30303094 DC : 0 BS EN ISO 10524-3 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
    13/30268585 DC : 0 BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT
    13/30242951 DC : 0 BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
    DIN EN ISO 18113-3:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
    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
    13/30245306 DC : 0 BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS
    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)
    10/30205392 DC : 0 BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    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
    I.S. EN ISO 23908:2013 SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011)
    UNE-EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
    BS EN 62083:2009 (published 2010-03) Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
    BS EN ISO 18113-3:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
    CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    BIS IS/ISO 15197 : 2013 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    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)
    ONORM EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
    AAMI ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
    AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    AAMI ISO 5361 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    ISO 16571:2014 Systems for evacuation of plume generated by medical devices
    I.S. EN ISO 10524-4:2008 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS
    I.S. EN 60601-2-66:2015 MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
    BS EN 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
    ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
    UNI CEI EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
    AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
    CSA C22.2 No. 60601.2.1 : 2011 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
    I.S. EN 1865-2:2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
    PD ISO/TS 17137:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
    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
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    DIN EN ISO 9680 E : 2015 DENTISTRY - OPERATING LIGHTS (ISO 9680:2014)
    BS EN 1782 : 1998 TRACHEAL TUBES AND CONNECTORS
    ISO 10524-4:2008 Pressure regulators for use with medical gases Part 4: Low-pressure regulators
    BS EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    ISO 7494-2:2015 Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems
    UNE-EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
    ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
    ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
    BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    I.S. EN ISO 11608-1:2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
    DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
    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 ISO 9680:2014 DENTISTRY - OPERATING LIGHTS (ISO 9680:2014)
    EN 13544-1:2007+A1:2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    BS EN ISO 15002:2008 (published 2008-08) Flow-metering devices for connection to terminal units of medical gas pipeline systems
    CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
    UNE-EN ISO 80369-1:2011 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
    09/30173644 DC : 0 BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    BS EN ISO 5359 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    UNE-EN ISO 11608-5:2013 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    15/30280196 DC : 0 BS ISO/IEC 25022 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - MEASUREMENT OF QUALITY IN USE
    NF EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
    08/30154605 DC : DRAFT APR 2008 BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
    UNI EN ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
    16/30216785 DC : 0 BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    DIN EN ISO 11608-5:2013-01 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012)
    I.S. EN 1865-3:2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
    11/30206856 DC : 0 BS EN 60601-1-8:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    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 80601-2-30 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    06/30146526 DC : 0 BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
    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
    I.S. EN ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
    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
    BS EN ISO 80369-1:2010 (published 2011-07) Small bore connectors for liquids and gases in healthcare applications General requirements
    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
    14/30281560 DC : 0 BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
    BS PD ISO/TS 19218-2 : 2012 MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 2: EVALUATION CODES
    DIN EN ISO 15002:2008-11 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
    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
    CAN/CSA-Z15002:12 (R2017) Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations)
    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
    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
    14/30294895 DC : 0 BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
    CSA Z1500:2012 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
    CSA C22.2 No. 60601.1.8 : 2008 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    BS EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications
    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
    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
    UNI EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
    UNE-EN ISO 10079-1:2016 Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
    UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
    I.S. EN 60601-1-6:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
    AAMI ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
    BS EN 60601-1-8 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006)
    CSA ISO 10079-3:14 (R2019) Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01)
    UNE-EN ISO 7494-1:2012 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
    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
    AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
    I.S. EN ISO 80369-3:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO/IEC/DIS 80369-3:2014)
    I.S. EN ISO 5840-1:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
    EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
    CEI UNI EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
    ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
    CSA C22.2 No. 60601.1.8 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    CAN/CSA-ISO 10079-1:16 Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01)
    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
    CSA C22.2 No. 80601-2-69 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
    CSA ISO 10079-2 : 2014 MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT
    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
    UNE-EN ISO 14457:2013 Dentistry - Handpieces and motors (ISO 14457:2012)
    BS EN ISO 5367 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
    UNE-EN ISO 5367:2015 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
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    IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
    I.S. EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
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    I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
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    I.S. EN 60601-1-8:2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
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    CSA C22.2 No. 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
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