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PD IEC/TR 60601-4-4:2017

Current
Current

The latest, up-to-date edition.

Medical electrical equipment Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-19-2017

Publisher

British Standards Institution

FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
4 Overview
5 Recommendations
Bibliography
Index of defined terms used in this document

Helps writers when drafting ALARM SYSTEM-related requirements for particular standards in the IEC 60601 and IEC 80601 or ISO 80601 series of standards.

IEC TR 60601-4-4:2017(E) is intended to assist writers when drafting alarm system-related requirements for particular standards in the IEC60601 and IEC80601 or ISO80601 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, IEC60601-1-8, contains the horizontal alarm system-related requirements for meequipment and mesystems. The recommendations in this document are intended to aid the writers of particular standards when referencing IEC60601-1-8:2006 and IEC60601-1-8:2006/AMD1:2012.

Committee
CH/62/1
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Current

Standards Relationship
IEC TR 60601-4-4:2017 Identical

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-72:2015 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
ISO 80601-2-61:2011 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance

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Hardcopy - English
PDF - English
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