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  • ANSI/AAMI HA60601-1-11:2015

    Current The latest, up-to-date edition.

    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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  25-08-2015

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of IEC 60601-1-11:2015
    Foreword
    U.S. Deviations to IEC 60601-1-11:2015
    Introduction
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 General requirements for testing ME EQUIPMENT
    6 Classification of ME EQUIPMENT and ME SYSTEMS
    7 ME EQUIPMENT identification,
       marking and documents
    8 Protection against excessive temperatures
       and other HAZARDS
    9 Accuracy of controls and instruments and
       protection against hazardous outputs
    10 Construction of ME EQUIPMENT
    11 Protection against strangulation or asphyxiation
    12 Additional requirements for ELECTROMAGNETIC
       EMISSIONS of ME EQUIPMENT and ME SYSTEMS
    13 Additional requirements for ALARM SYSTEMS of
       ME EQUIPMENT and ME 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 (informative) - Symbols on marking
    Bibliography
    Index of defined terms used in this collateral standard

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.

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

    Committee HA
    Development Note New child AMD 1 2021 is added.
    Document Type Standard
    Product Note New child AMD 1 2021 is added.
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    AAMI TIR49 : 2013 DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS

    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 60038:2009 IEC standard voltages
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    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
    MIL-STD-810 Revision G:2008 ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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 8124-1:2014 Safety of toys Part 1: Safety aspects related to mechanical and physical properties
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    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 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    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
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
    MIL-HDBK-310 Base Document:1997 DEPARTMENT OF DEFENSE HANDBOOK - GLOBAL CLIMATIC DATA FOR DEVELOPING MILITARY PRODUCTS
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 61032:1997 Protection of persons and equipment by enclosures - Probes for verification
    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 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
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