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AAMI IEC 60601-2-27:2011(R2016)

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Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-06-2017

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 60601-2-27:2011
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
       and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
       HAZARDS
201.11 Protection against excessive temperatures and other
       HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
       ME SYSTEMS
202 Electromagnetic compatibility - Requirements and
       tests
208 General requirements, tests and guidance for
       alarm systems in medical electrical equipment
       and medical electrical systems
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Alarm diagrams of Clause
                         208/IEC 60601-1-8:2006
Bibliography
Index of defined terms used in this particular standard

Pertains to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT and hereinafter also referred to as ME EQUIPMENT.

DevelopmentNote
Supersedes AAMI EC13. (09/2011)
DocumentType
Standard
ISBN
978-1-57020-404-3
Pages
86
ProductNote
Reconfirmed 2016
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
IEC 60601-2-27:2011 Identical

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 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

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