IEC TR 62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements《IEC 60601-1第2版中未提到的安全方面的考虑和对新要求的建议》.pdf
《IEC TR 62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements《IEC 60601-1第2版中未提到的安全方面的考虑和对新要求的建议》.pdf》由会员分享,可在线阅读,更多相关《IEC TR 62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements《IEC 60601-1第2版中未提到的安全方面的考虑和对新要求的建议》.pdf(82页珍藏版)》请在麦多课文档分享上搜索。
1、 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) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless oth
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10、on 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 XC ICS 11.040 PRICE CODE ISBN 2-8318-1025-1 Registered trademark of the International Electrotechnical Commis
11、sion 2 TR 62296 IEC:2009(E) CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope and object7 1.1 Scope7 1.2 Object .7 2 Recommendations7 2.1 Summary of all recommendations prepared by SC 62A/WG 147 2.2 Recommendation sheets .10 2.2.1 Separation: Reliability of component impedance10 2.2.2 Separation: Non-compl
12、ying creepage distance and air clearances.12 2.2.3 Mains supply transformers: Overload test13 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 reliability1
13、7 2.2.8 ENCLOSURES and protective covers18 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: L
14、ampholder/switching device22 2.2.13 Fixing, prevention of maladjustment: Torque test.23 2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries24 2.2.15 Excessive temperatures: Ambient temperatures 25 2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS .26 2.2.17 ENCLOSURE
15、and protective covers: EQUIPMENT in ambulances27 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 p
16、aragraph31 2.2.22 Limitation of voltage and/or energy: Capacitance.32 2.2.23 LEAKAGE CURRENTS: Presence of 45 k 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 req
17、uirements for tests: Measurement uncertainty .36 2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES: Interpolated values37 2.2.28 Overheating: Change of load resistance 38 2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of external protective earth39 2.2.30 Rechargeable batteries:
18、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 1942 2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from INTERNALLY POWERED EQUIPMENT 43 2.2.34 Marking on the outside of EQUIPMENT:
19、 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
20、PART: EQUIPMENT worn by PATIENTS .48 2.2.39 Construction: Triple insulated winding wire49 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 DIST
21、ANCES and AIR CLEARANCES POWER SUPPLY CORDS51 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: Thermocoupl
22、e 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-OUTLET59 2.2.50 Separation, DEFIBRILLATION-PROOF APPL
23、IED 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 liquids63 2.2.54 Mains supply transformers.64 2.2.55 Dielectric strength:
24、Reliability of components to bridge A-a 2and 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
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