IEC TR 62296:2009
(Main)Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
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.
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IEC/TR 62296 ®
Edition 2.0 2009-01
TECHNICAL
REPORT
Considerations of unaddressed safety aspects in the second edition of
IEC 60601-1 and proposals for new requirements
IEC/TR 62296:2009(E)
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IEC/TR 62296 ®
Edition 2.0 2009-01
TECHNICAL
REPORT
Considerations of unaddressed safety aspects in the second edition of
IEC 60601-1 and proposals for new requirements
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XC
ICS 11.040 ISBN 978-2-88910-665-3
– 2 – TR 62296 © IEC:2009(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope and object.7
1.1 Scope.7
1.2 Object .7
2 Recommendations.7
2.1 Summary of all recommendations prepared by SC 62A/WG 14.7
2.2 Recommendation sheets .10
2.2.1 Separation: Reliability of component impedance .10
2.2.2 Separation: Non-complying creepage distance and air clearances.12
2.2.3 Mains supply transformers: Overload test .13
2.2.4 Mains supply transformers: Short circuit and overload tests.14
2.2.5 Creepage distance and air clearances: Values .15
2.2.6 Dielectric strength .16
2.2.7 Failure of components: Evidence of reliability .17
2.2.8 ENCLOSURES and protective covers .18
2.2.9 INTERNALLY POWERED EQUIPMENT: 110 % of the maximum supply
voltage .19
2.2.10 Creepage distances and air clearances: Values under 1 mm .20
2.2.11 Separation: Secondary circuit impedance limit LEAKAGE CURRENT.21
2.2.12 ENCLOSURES and PROTECTIVE COVERS: Lampholder/switching device.22
2.2.13 Fixing, prevention of maladjustment: Torque test.23
2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries.24
2.2.15 Excessive temperatures: Ambient temperatures .25
2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS .26
2.2.17 ENCLOSURE and protective covers: EQUIPMENT in ambulances.27
2.2.18 Dielectric strength: Voltages appearing from external sources .28
2.2.19 Testing switch mode power supply units (SMPSU).29
2.2.20 Failure of an electrical component: Time periodicity for detection .30
2.2.21 Environmental conditions: Compliance paragraph.31
2.2.22 Limitation of voltage and/or energy: Capacitance.32
2.2.23 LEAKAGE CURRENTS: Presence of 45 kΩ resistor in Figure 21 .33
2.2.24 Humidity preconditioning treatment: Exception from requirement.34
2.2.25 Dielectric strength: EQUIPMENT containing floating circuits .35
2.2.26 General requirements for tests: Measurement uncertainty .36
2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES: Interpolated values.37
2.2.28 Overheating: Change of load resistance .38
2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of
external protective earth .39
2.2.30 Rechargeable batteries: No OPERATOR/USER maintenance .40
2.2.31 Isolation from the SUPPLY MAINS: Symbol for single pole switch .41
2.2.32 Sequence of testing: Clause 52 before Clause 19.42
2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from
INTERNALLY POWERED EQUIPMENT .43
2.2.34 Marking on the outside of EQUIPMENT: Type and rating of fuses .44
2.2.35 Excessive temperatures: APPLIED PARTS not intended to supply heat .45
2.2.36 Mains supply transformers: Use of PTCs as protective devices .46
TR 62296 © IEC:2009(E) – 3 –
2.2.37 Components and general assembly: Reliability of components .47
2.2.38 Definition of APPLIED PART: EQUIPMENT worn by PATIENTS .48
2.2.39 Construction: Triple insulated winding wire .49
2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test
versus CREEPAGE DISTANCES and AIR CLEARANCES .50
2.2.41 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test
versus CREEPAGE DISTANCES and AIR CLEARANCES – POWER SUPPLY
CORDS.51
2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or electronic file format .52
2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements for lithium
batteries .53
2.2.44 Dielectric strength: Differences between B-d and B-e .54
2.2.45 Excessive temperatures: Thermocouple instead of resistance method.55
2.2.46 Mains fuses and OVER-CURRENT RELEASEs: Fuses in CLASS II
EQUIPMENT .56
2.2.47 Plug in power supply .57
2.2.48 Connecting cords between EQUIPMENT parts: Other applications .58
2.2.49 MULTIPLE PORTABLE SOCKET-OUTLET.59
2.2.50 Separation, DEFIBRILLATION-PROOF APPLIED PART: multiple APPLIED
PARTS .60
2.2.51 Separation, APPLIED PART: Hand held flexible shafts.61
2.2.52 Protective earthing: No-load voltage of 6 V maximum .62
2.2.53 Foot-operated control devices: Protection against entry of liquids.63
2.2.54 Mains supply transformers.64
2.2.55 Dielectric strength: Reliability of components to bridge A-a and B-a.65
2.2.56 Dielectric strength: A-e in switch mode power supply units (SMPSU).66
2.2.57 Dielectric strength: Connection of 12 V dc negative side to
ENCLOSURE .67
2.2.58 Dielectric strength: Voltages appearing on SIP/SOP .68
2.2.59 APPLIED PART: EQUIPMENT without APPLIED PART .69
2.2.60 Scope: Other than MEDICAL ELECTRICAL EQUIPMENT in contact with the
body of a person.70
2.2.61 Markings: AC symbol.71
2.2.62 Interruption of power supply: Characteristics of interruption.72
2.2.63 Reference voltage: Different reference voltages in the same circuit .73
Bibliography.74
Index of Terms.76
– 4 – TR 62296 © IEC:2009(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS
IN THE SECOND EDITION OF IEC 60601-1 AND
PROPOSALS FOR NEW REQUIREMENTS
FOREWORD
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