IEC TR 60601-4-4:2017

Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements

IEC TR 60601-4-4:2017(E) is intended to assist writers when drafting alarm system-related requirements for particular standards in the IEC 60601 and IEC 80601 or ISO 80601 series of standards.
The object of this document is to encourage consistent references to alarm system-related requirements when introducing those requirements to particular standards. This is accomplished by providing suggested model language, with examples, for common alarm system-related requirements. Each of the recommendations is based upon text that has been used in existing particular standards. The expectation is that this model language will be used when alarm system-related requirements are needed in particular standards.
The collateral standard for alarm systems, IEC 60601-1-8, contains the horizontal alarm system-related requirements for me equipment and me systems. The recommendations in this document are intended to aid the writers of particular standards when referencing IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012.

General Information

• Status: Published
• Publication Date: 16-Aug-2017
• 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
• Current Stage: PPUB - Publication issued
• Start Date: 05-Sep-2017
• Completion Date: 17-Aug-2017

Standards Content (Sample)

IEC TR 60601-4-4
®

Edition 1.0 2017-08
TECHNICAL
REPORT



Medical electrical equipment –
Part 4-4: Guidance and interpretation – Guidance for writers of particular
standards when creating alarm system-related requirements
IEC TR 60601-4-4:2017-08(en)

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IEC TR 60601-4-4

®


Edition 1.0 2017-08




TECHNICAL



REPORT



















Medical electrical equipment –

Part 4-4: Guidance and interpretation – Guidance for writers of particular

standards when creating alarm system-related requirements

























INTERNATIONAL

ELECTROTECHNICAL


COMMISSION





ICS 11.040.01 ISBN 978-2-8322-4685-6



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® Registered trademark of the International Electrotechnical Commission

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– 2 – IEC TR 60601-4-4:2017 © IEC 2017
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 7
1.1 Scope . 7
1.2 Object . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Overview . 8
5 Recommendations .
...