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CEI EN 60601-2-25 : 2016

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

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 colour codes
Annex CC (informative) - LEADS, their identification and
         colour 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
Annex ZA (normative) - Normative references to
         international publications with their corresponding
         European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

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.

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-76 (09/2001) Supersedes CEI 62-15 (03/2004) Supersedes CEI EN 60601-2-51 which remains current and will be withdrawn on 15-09-2018. 1ED 1996 Edition along with its amendment is valid until 15-09-2018. (05/2016)
DocumentType
Standard
Pages
104
PublisherName
Comitato Elettrotecnico Italiano
Status
Current
Supersedes

Standards Relationship
IEC 60601-2-25:2011 Identical
EN 60601-2-25:2015 Identical

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
EN 60601-1-2:2015 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

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