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  • IEC TR 62354:2014

    Current The latest, up-to-date edition.

    General testing procedures for medical electrical equipment

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

    Language(s):  English

    Published date:  25-09-2014

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope and object
    2 Normative references
    3 Terms, definitions, abbreviations and acronyms
    4 Types of tests
    5 State of the ME EQUIPMENT
    6 Number of samples
    7 Applicable test items to the clauses of IEC 60601-1
    8 Sequence of tests
    9 General testing condition
    10 Power sources for tests
    11 Measurement and test equipment
    12 Treatments of unit symbols and measured values
    13 PROCEDURES for testing, including particular
       conditions
    Annex A (informative) - Sequence of testing
    Annex B (informative) - Information typically required
            for product safety testing (Guide)
    Annex C (informative) - Testing and measuring equipment
    Annex D (informative) - Suitable measuring supply circuits
    Annex E (informative) - Preventive maintenance
    Annex F (informative) - Test probes
    Annex G (informative) - Index of tests (IEC 60601-1:2005
            clauses order)
    Annex H (informative) - Index of tests for an
            INTERNALLY POWERED EQUIPMENT - battery only -
            (IEC 60601-1:2005 clauses order)
    Annex I (informative) - Index of tests (IEC 60601-1:2005
            alphabetic order)
    Annex J (informative) - Index of tests for an INTERNALLY
            POWERED EQUIPMENT - battery only -
            (IEC 60601-1:2005 alphabetic order)
    Annex K (informative) - Production line tests
    Annex L (informative) - Evaluation of the laboratory
            power source characteristics
    Annex M (informative) - Traceability of calibrations
            and calibration intervals
    Annex N (informative) - Guidance for preparation,
            attachment, extension, use of thermocouples and
            acceptance of thermocouple wire
    Annex O (informative) - Guideline for safe laboratory work
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    IEC TR 62354:2014 applies to medical electrical equipment. The object of this technical report is to provide guidance on general testing procedures according to IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. This third edition cancels and replaces the second edition published in 2009. This edition constitutes a technical revision intended to align the guidance in this technical report with Amendment 1 to IEC 60601:2005. Several tests have been updated and additional test procedures added.

    This technical report is to be read in conjunction with IEC 60601-1:1988, IEC 60601-1-1:2000 and IEC 60601-1:2005.

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

    Committee TC 62/SC 62A
    Development Note Stability date: 2019. (09/2014)
    Document Type Technical Report
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    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)
    11/30193150 DC : 0 BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    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 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    CSA C22.2 No. 60601.1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

    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 60320-1:2015 Appliance couplers for household and similar general purposes - Part 1: General requirements
    IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    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
    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    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
    IEC 60364-4-41:2005+AMD1:2017 CSV Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV Plugs and socket-outlets for household and similar purposes - Part1: General requirements
    ISO 13852:1996 Safety of machinery Safety distances to prevent danger zones being reached by the upper limbs
    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
    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
    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/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 80000-1:2009 Quantities and units — Part 1: General
    ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
    IEC 60252-1:2010+AMD1:2013 CSV AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation
    IEC 61010-031:2015 RLV Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test
    IEC 61557-4:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 4: Resistance of earth connection and equipotential bonding
    IEC 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
    ISO 471:1995 Rubber Temperatures, humidities and times for conditioning and testing
    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 1853:2011 Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity
    IEC 61032:1997 Protection of persons and equipment by enclosures - Probes for verification
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    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
    IEC TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
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