• AAMI ES60601-1 : 2005 : R2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-05-2020

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Association for the Advancement of Medical Instrumentation

    Add To Cart

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of IEC 60601-1:2005
    AAMI deviations from IEC 60601-1:2005
    Foreword
    Introduction
    1 Scope, object, and related standards
       1.1 Scope
       1.2 Object
       1.3 Collateral standards
       1.4 Particular standards
    2 Normative references
    3 Terminology and definitions
    4 General requirements
       4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
       4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
       4.3 ESSENTIAL PERFORMANCE
       4.4 EXPECTED SERVICE LIFE
       4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
       4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
       4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
       4.8 Components of ME EQUIPMENT
       4.9 Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in
             ME EQUIPMENT
       4.10 Power supply
       4.11 Power input
    5 General requirements for testing ME EQUIPMENT
       5.1 TYPE TESTS
       5.2 Number of samples
       5.3 Ambient temperature, humidity, atmospheric pressure
       5.4 Other conditions
       5.5 Supply voltages, type of current, nature of supply,
             frequency
       5.6 Repairs and modifications
       5.7 Humidity preconditioning treatment
       5.8 Sequence of tests
       5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
    6 Classification of ME EQUIPMENT and ME SYSTEMS
       6.1 General
       6.2 Protection against electric shock
       6.3 Protection against harmful ingress of water or
             particulate matter
       6.4 Method(s) of sterilization
       6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT
       6.6 Mode of operation
    7 ME EQUIPMENT identification, marking, and documents
       7.1 General
       7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
       7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
       7.4 Marking of controls and instruments
       7.5 Safety signs
       7.6 Symbols
       7.7 Colors of the insulation of conductors
       7.8 Indicator lights and controls
       7.9 ACCOMPANYING DOCUMENTS
    8 Protection against electrical HAZARDS from ME EQUIPMENT
       8.1 Fundamental rule of protection against electric shock
       8.2 Requirements related to power sources
       8.3 Classification of APPLIED PARTS
       8.4 Limitation of voltage, current, or energy
       8.5 Separation of parts
       8.6 Protective earthing, functional earthing, and potential
             equalization of ME EQUIPMENT
       8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
       8.8 Insulation
       8.9 CREEPAGE DISTANCES and AIR CLEARANCES
       8.10 Components and wiring
       8.11 MAINS PARTS, components, and layout
    9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
       ME SYSTEMS
       9.1 MECHANICAL HAZARDS of ME EQUIPMENT
       9.2 HAZARDS associated with moving parts
       9.3 HAZARD associated with surfaces, corners, and edges
       9.4 Instability HAZARDS
       9.5 Expelled parts HAZARD
       9.6 Acoustic energy (including infra- and ultrasound)
             and vibration
       9.7 Pressure vessels and parts subject to pneumatic
             and hydraulic pressure
       9.8 HAZARDS associated with support systems
    10 Protection against unwanted and excessive radiation HAZARDS
       10.1 X-Radiation
       10.2 Alpha, beta, gamma, neutron, and other particle radiation
       10.3 Microwave radiation
       10.4 Lasers and light emitting diodes
       10.5 Other visible electromagnetic radiation
       10.6 Infrared radiation
       10.7 Ultraviolet radiation
    11 Protection against excessive temperatures and other HAZARDS
       11.1 Excessive temperatures in ME EQUIPMENT
       11.2 Fire prevention
       11.3 Constructional requirements for fire ENCLOSURES of
             ME EQUIPMENT
       11.4 ME EQUIPMENT and ME SYSTEMS intended for use with
             flammable anesthetics
       11.5 ME EQUIPMENT and ME SYSTEMS intended for use in
             conjunction with flammable agents
       11.6 Overflow, spillage, leakage, ingress of water or
             particulate matter, cleaning, disinfection,
             sterilization, and compatibility with substances
             used with the ME EQUIPMENT
       11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
       11.8 Interruption of the power supply/SUPPLY MAINS to ME
             EQUIPMENT
    12 Accuracy of controls and instruments and protection against
       hazardous outputs
       12.1 Accuracy of controls and instruments
       12.2 USABILITY
       12.3 Alarm systems
       12.4 Protection against hazardous output
    13 HAZARDOUS SITUATIONS and fault conditions
       13.1 Specific HAZARDOUS SITUATIONS
       13.2 SINGLE FAULT CONDITIONS
    14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
       14.1 General
       14.2 Documentation
       14.3 RISK MANAGEMENT plan
       14.4 PEMS DEVELOPMENT LIFE-CYCLE
       14.5 Problem resolution
       14.6 RISK MANAGEMENT PROCESS
       14.7 Requirement specification
       14.8 Architecture
       14.9 Design and implementation
       14.10 VERIFICATION
       14.11 PEMS VALIDATION
       14.12 Modification
       14.13 Connection of PEMS by NETWORK/DATA COUPLING to other
             equipment
    15 Construction of ME EQUIPMENT
       15.1 Arrangements of controls and indicators of ME EQUIPMENT
       15.2 Serviceability
       15.3 Mechanical strength
       15.4 ME EQUIPMENT components and general assembly
       15.5 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and
             transformers providing separation in accordance with 8.5
    16 ME SYSTEMS
       16.1 General requirements for the ME SYSTEMS
       16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM
       16.3 Power supply
       16.4 ENCLOSURES
       16.5 SEPARATION DEVICES
       16.6 LEAKAGE CURRENTS
       16.7 Protection against MECHANICAL HAZARDS
       16.8 Interruption of the power supply to parts of an ME SYSTEM
       16.9 ME SYSTEM connections and wiring
    17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
    Annexes
    A - General guidance and rationale
    B - Sequence of testing
    C - Guide to marking and labelling requirements for ME EQUIPMENT
        and ME SYSTEMS
    D - Symbols on marking
    E - Examples of the connection of the measuring device (MD) for
        measurement of the PATIENT LEAKAGE CURRENT and PATIENT
        AUXILIARY CURRENT
    F - Suitable measuring supply circuits
    G - Protection against HAZARDS of ignition of flammable
        anesthetic mixtures
    H - PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE, and documentation
    I - ME SYSTEMS aspects
    J - Survey of insulation paths
    K - Simplified PATIENT LEAKAGE CURRENT diagrams
    L - Insulated winding wires for use without interleaved insulation
    Bibliography
    Index
    Index of abbreviations and acronyms

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

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

    Development Note Supersedes AAMI ES1. (02/2006) AMD 1 2012 includes AMD C1 2009 & AMD 2 2010. (05/2015)
    Document Type Standard
    Product Note Reconfirmed 2012
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    IEC 60112:2003+AMD1:2009 CSV Method for the determination of the proof and the comparative tracking indices of solid insulating materials
    IEC 60320-1:2015 Appliance couplers for household and similar general purposes - Part 1: General requirements
    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    IEC 61558-2-1:2007 Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications
    IEC 60245-1:2003+AMD1:2007 CSV Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC 60384-14:2013+AMD1:2016 CSV Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains
    UL 1439 : 5 TESTS FOR SHARPNESS OF EDGES ON EQUIPMENT
    IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    IEC 60127-6:2014 Miniature fuses - Part 6: Fuse-holders for miniature fuse-links
    IEC 60050-195:1998 International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock
    UL 2556 : 4 WIRE AND CABLE TEST METHODS
    IEC 60695-1-1:1999 Fire hazard testing - Part 1-1: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
    IEC 60364-4-41:2005+AMD1:2017 CSV Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock
    IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
    IEC 61558-2-4:2009 Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1 100 V - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers
    IEC TR 62354:2014 General testing procedures for medical electrical equipment
    ISO 23529:2016 Rubber General procedures for preparing and conditioning test pieces for physical test methods
    ISO 2882:1979 Rubber, vulcanized Antistatic and conductive products for hospital use Electrical resistance limits
    ISO 9614-1:1993 Acoustics Determination of sound power levels of noise sources using sound intensity Part 1: Measurement at discrete points
    IEC 60050-151:2001 International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices
    IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV Plugs and socket-outlets for household and similar purposes - Part1: General requirements
    IEC 61000-4-11:2004+AMD1:2017 CSV Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
    IEC 60050-441:1984 International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 60332-2-2:2004 Tests on electric and optical fibre cables under fire conditions - Part 2-2: Test for vertical flame propagation for a single small insulated wire or cable - Procedure for diffusion flame
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    IEC 61558-2-23:2010 Safety of transformers, reactors, power supply units and combinations thereof - Part 2-23: Particular requirements and tests for transformers and power supply units for construction sites
    IEC 60601-1-8:2006+AMD1:2012 CSV 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
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links
    IEC 60851-6:2012 Winding wires - Test methods - Part 6: Thermal properties
    IEC 60079-5:2015 RLV Explosive atmospheres - Part 5: Equipment protection by powder filling "q"
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    IEC 60851-5:2008+AMD1:2011 CSV Winding wires - Test methods - Part 5: Electrical properties
    IEC 60227-1:2007 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements
    IEC 60332-1-2:2004+AMD1:2015 CSV Tests on electric and optical fibre cables under fire conditions - Part 1-2: Test for vertical flame propagation for a single insulatedwire or cable - Procedure for 1 kW pre-mixed flame
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    EN 563:1994/A1:1999/AC:2000 SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES
    IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 60085:2007 Electrical insulation - Thermal evaluation and designation
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC 61558-1:2017 Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    IEC 60447:2004 Basic and safety principles for man-machine interface, marking and identification - Actuating principles
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    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
    MIL HDBK 217 : F RELIABILITY PREDICTION OF ELECTRONIC EQUIPMENT
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC 61058-1:2016 Switches for appliances - Part 1: General requirements
    NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
    IEC 60068-2-2:2007 Environmental testing - Part 2-2: Tests - Test B: Dry heat
    IEC 60695-11-10:2013 Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    IEC 60079-6:2015 Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o"
    IEC 60079-0:2011 Explosive atmospheres - Part 0: Equipment - General requirements
    ISO 8041:2005 Human response to vibration Measuring instrumentation
    IEC 60851-3:2009+AMD1:2013 CSV Winding wires - Test methods - Part 3: Mechanical properties
    IEC 62079:2001 Preparation of instructions - Structuring, content and presentation
    ISO 80000-1:2009 Quantities and units Part 1: General
    ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs
    ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
    IEC 60086-1:2015 Primary batteries - Part 1: General
    IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    ISO 3864-1:2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings
    IEC 60252-1:2010+AMD1:2013 CSV AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    IEC 60050-826:2004 International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations
    IEC 61965:2003 Mechanical safety of cathode ray tubes
    IEC 60364-7-707:1984 Electrical installations of buildings. Part 7: Requirements for special installations or locations. Section 707: Earthing requirements for the installation of data processing equipment
    ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
    IEC 62133 : 2.0EN+(REDLINE+VERSION) SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES - SAFETY REQUIREMENTS FOR PORTABLE SEALED SECONDARY CELLS, AND FOR BATTERIES MADE FROM THEM, FOR USE IN PORTABLE APPLICATIONS
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 60086-4:2014 Primary batteries - Part 4: Safety of lithium batteries
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 60317-43:1997+AMD1:2010 CSV Specifications for particular types of winding wires - Part 43: Aromatic polyimide type wrapped round copper wire, class 240
    IEC 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    ISO 1853:2011 Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity
    IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60695-1-10:2016 Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
    IEC 60445:2017 Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors
    IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    IEC 60990:2016 Methods of measurement of touch current and protective conductor current
    ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 5805:1997 Mechanical vibration and shock Human exposure Vocabulary
    IEC 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
    ISO 7396-1:2016 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective