• PD IEC/TR 62296:2009

    Current The latest, up-to-date edition.

    Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  22-01-2009

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1 Scope and object
      1.1 Scope
      1.2 Object
    2 Recommendations
      2.1 Summary of all recommendations prepared by SC 62A/WG 14
      2.2 Recommendation sheets
          2.2.1 Separation: Reliability of component impedance
          2.2.2 Separation: Non-complying creepage distance and
                 air clearances
          2.2.3 Mains supply transformers: Overload test
          2.2.4 Mains supply transformers: Short circuit and
                 overload tests
          2.2.5 Creepage distance and air clearances: Values
          2.2.6 Dielectric strength
          2.2.7 Failure of components: Evidence of reliability
          2.2.8 ENCLOSURES and protective covers
          2.2.9 INTERNALLY POWERED EQUIPMENT: 110% of the maximum
                 supply voltage
          2.2.10 Creepage distances and air clearances: Values
                 under 1 mm
          2.2.11 Separation: Secondary circuit impedance limit
                 LEAKAGE CURRENT
          2.2.12 ENCLOSURES and PROTECTIVE COVERS:
                 Lampholder/switching device
          2.2.13 Fixing, prevention of maladjustment: Torque test
          2.2.14 Batteries not intended to be changed by OPERATOR:
                 Lithium batteries
          2.2.15 Excessive temperatures: Ambient temperatures
          2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS
          2.2.17 ENCLOSURE and protective covers: EQUIPMENT in
                 ambulances
          2.2.18 Dielectric strength: Voltages appearing from
                 external sources
          2.2.19 Testing switch mode power supply units (SMPSU)
          2.2.20 Failure of an electrical component: Time periodicity
                 for detection
          2.2.21 Environmental conditions: Compliance paragraph
          2.2.22 Limitation of voltage and/or energy: Capacitance
          2.2.23 LEAKAGE CURRENTS: Presence of 45 k ohms resistor in
                 Figure 21
          2.2.24 Humidity preconditioning treatment: Exception
                 from requirement
          2.2.25 Dielectric strength: EQUIPMENT containing
                 floating circuits
          2.2.26 General requirements for tests: Measurement
                 uncertainty
          2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES:
                 Interpolated values
          2.2.28 Overheating: Change of load resistance
          2.2.29 Mains operated EQUIPMENT with additional power
                 source: Integrity of external protective earth
          2.2.30 Rechargeable batteries: No OPERATOR/USER maintenance
          2.2.31 Isolation from the SUPPLY MAINS: Symbol for single
                 pole switch
          2.2.32 Sequence of testing: Clause 52 before Clause 19
          2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT
                 from INTERNALLY POWERED EQUIPMENT
          2.2.34 Marking on the outside of EQUIPMENT: Type and
                 rating of fuses
          2.2.35 Excessive temperatures: APPLIED PARTS not intended
                 to supply heat
          2.2.36 Mains supply transformers: Use of PTCs as
                 protective devices
          2.2.37 Components and general assembly: Reliability of
                 components
          2.2.38 Definition of APPLIED PART: EQUIPMENT worn by
                 PATIENTS
          2.2.39 Construction: Triple insulated winding wire
          2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES:
                 Dielectric strength test versus CREEPAGE
                 DISTANCES and AIR CLEARANCES
          2.2.41 CREEPAGE DISTANCES and AIR CLEARANCES:
                 Dielectric strength test versus CREEPAGE
                 DISTANCES and AIR CLEARANCES - POWER SUPPLY CORDS
          2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or electronic
                 file format
          2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements
                 for lithium batteries
          2.2.44 Dielectric strength: Differences between B-d and B-e
          2.2.45 Excessive temperatures: Thermocouple instead of
                 resistance method
          2.2.46 Mains fuses and OVER-CURRENT RELEASEs: Fuses in
                 CLASS II EQUIPMENT
          2.2.47 Plug in power supply
          2.2.48 Connecting cords between EQUIPMENT parts: Other
                 applications
          2.2.49 MULTIPLE PORTABLE SOCKET-OUTLET
          2.2.50 Separation, DEFIBRILLATION-PROOF APPLIED PART:
                 multiple APPLIED PARTS
          2.2.51 Separation, APPLIED PART: Hand held flexible shafts
          2.2.52 Protective earthing: No-load voltage of 6 V maximum
          2.2.53 Foot-operated control devices: Protection against
                 entry of liquids
          2.2.54 Mains supply transformers
          2.2.55 Dielectric strength: Reliability of components to
                 bridge A-a[2] and B-a
          2.2.56 Dielectric strength: A-e in switch mode power
                 supply units (SMPSU)
          2.2.57 Dielectric strength: Connection of 12 V dc negative
                 side to ENCLOSURE
          2.2.58 Dielectric strength: Voltages appearing on SIP/SOP
          2.2.59 APPLIED PART: EQUIPMENT without APPLIED PART
          2.2.60 Scope: Other than MEDICAL ELECTRICAL EQUIPMENT in
                 contact with the body of a person
          2.2.61 Markings: AC symbol
          2.2.62 Interruption of power supply: Characteristics of
                 interruption
          2.2.63 Reference voltage: Different reference voltages in
                 the same circuit
    Bibliography
    Index of Terms

    Abstract - (Show below) - (Hide below)

    Provides a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1.

    Scope - (Show below) - (Hide below)

    IEC/TR 62296:2009(E) contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1. IEC/TR 62296:2009(E) is primarily intended to be used by:
    - manufacturers of medical electrical equipment;
    - test houses and others responsible for assessment of compliance with IEC 60601-1:1988, and
    - those developing subsequent editions of IEC 60601-1.
    The recommendations in the first edition of IEC/TR 62296 were considered in preparing the third edition of IEC 60601-1. As the third edition of IEC 60601-1 has been published, some of the recommendations in the second edition of IEC/TR 62296 have been changed to align with requirements in IEC 60601-1:2005. Seven additional recommendations have been developed by IEC/SC 62A/WG 14 and are included in this edition of IEC/TR 62296. They are recommendations 57 through 63. This second edition cancels and replaces the first edition published in 2003. It constitutes a technical revision. This edition includes seven new recommendations: Recommendations 57 through 63. As the third edition of IEC 60601-1 has been published, some of the recommendations in this edition have been changed to align with requirements in IEC 60601-1:2005.

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

    Committee CH/62/1
    Development Note Supersedes 02/562754 DC (09/2003)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

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    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 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    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
    IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links
    IEC 60127-2:2014 Miniature fuses - Part 2: Cartridge fuse-links
    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 61558-1:2017 Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC TR 60930:2008 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
    IEC 60664-3:2016 Insulation coordination for equipment within low-voltage systems - Part 3: Use of coating, potting or moulding for protection against pollution
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
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