IEC TR 62296:2009

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.

General Information

• Status: Published
• Publication Date: 21-Jan-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: WG 14 - TC 62/SC 62A/WG 14
• Current Stage: PPUB - Publication issued
• Start Date: 31-Mar-2009
• Completion Date: 22-Jan-2009

Standards Content (Sample)

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)

---------------------- Page: 1 ----------------------
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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
® Registered trademark of the International Electrotechnical Commission

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– 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 .
...