IEC TR 60601-4-3:2018

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

IEC TR 60601-4-3:2018 is available as IEC TR 60601-4-3:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC TR 60601-4-3:2018 contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of IEC 60601-1:2005 and related collateral standards in the IEC 60601 series. IEC TR 60601-4-3:2018 is primarily intended to be used by:
– manufacturers of medical electrical equipment;
– test laboratories and others responsible for assessment of compliance with IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:2010, IEC 60601 1 11:2015 and IEC 60601-1-12:2014;
– 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. Similarly, it is expected that these recommendations within IEC 60601-4-3 will be considered when preparing future revisions of IEC 60601-1 and related collateral standards in the IEC 60601 series. The object of IEC TR 60601-4-3:2018 is to make the recommendations/interpretations available to those interested in the application of the third edition of IEC 60601-1 and applicable collateral standards. IEC TR 60601-4-3:2018 cancels and replaces the first edition of IEC 60601-4-3 published in 2015. This edition constitutes a technical revision. IEC TR 60601-4-3:2018 includes the following significant technical changes with respect to the previous edition: addition of 47 new recommendations.

General Information

• Status: Published
• Publication Date: 12-Dec-2018
• 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: 25-Dec-2018
• Completion Date: 13-Dec-2018

Relations

• Revises: IEC TR 60601-4-3:2015 - Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC TR 60601-4-3
®


Edition 2.0 2018-12
TECHNICAL
REPORT

colour
inside


Medical electrical equipment –
Part 4-3: Guidance and interpretation – Considerations of unaddressed safety
aspects in the third edition of IEC 60601-1 and proposals for new requirements

IEC TR 60601-4-3:2018-12en)

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IEC TR 60601-4-3

®


Edition 2.0 2018-12




TECHNICAL



REPORT








colour

inside










Medical electrical equipment –

Part 4-3: Guidance and interpretation – Considerations of unaddressed safety

aspects in the third edition of IEC 60601-1 and proposals for new requirements


























INTERNATIONAL

ELECTROTECHNICAL


COMMISSION





ICS 11.040.01 ISBN 978-2-8322-6278-8




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® Registered trademark of the International Electrotechnical Commission

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– 2 – IEC TR 60601-4-3:2018  IEC 2018
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 11
4 Recommendations . 11
4.1 Template used for recommendations prepared by SC 62A . 11
4.2 Recommendation sheets . 12
4.2.101 Total PATIENT LEAKAGE CURRENT of a ME SYSTEM .
...