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AAMI/IEC TIR62296:2009

Current
Current

The latest, up-to-date edition.

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-04-2009

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of 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 percent 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 ohm 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
             INTERNALLYY 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-a2 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

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.

Committee
ES
DocumentType
Technical Report
ISBN
1570203458
Pages
86
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
IEC TR 62296:2009 Identical

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
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
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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