IEC TR 62296:2009

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

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.