Name: AAMI IEC 60601-2-25 : 2011
Brand: AAMI

AAMI IEC 60601-2-25 : 2011

Superseded

MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS

Available format(s)

Hardcopy , PDF

Superseded date

09-02-2021

Language(s)

English

Published date

01-01-2016

Publisher

Association for the Advancement of Medical Instrumentation

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
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - ELECTRODES, their positions,
         identifications and color codes
Annex CC (informative) - LEADS, their identification and
         color codes
Annex DD (informative) - Polarity of PATIENT LEADS
Annex EE (informative) - Additional marking of ELECTRODES
Annex FF (informative) - Definitions and rules for the
         measurement of ELECTROCARDIOGRAMS
Annex GG (informative) - Calibration and test data sets
Annex HH (informative) - CTS test atlas
Bibliography
Index of defined terms used in this particular standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS intended by themselves or as a part of an ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to as ME EQUIPMENT.

DevelopmentNote	Supersedes AAMI EC11. (06/2012)
DocumentType	Standard
Pages	108
ProductNote	Reconfirmed 2011
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	ANSI/AAMI/IEC 60601-2-25:2011(R2016)
Supersedes	AAMI EC11 : 1991

Standards	Relationship
IEC 60601-2-25:2011	Identical

IEC 60601-2-47:2012	Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic 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 60601-2-27:2011	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment