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EN 60601-2-25:2015

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
Published date

23-10-2015

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 (other than those specified in 201.12.4.102)
Annex DD (informative) - Polarity of PATIENT LEADS (other than
         those specified in 201.12.4.102)
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

IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are: a) the part of Medical electrical equipment that provides vectorcardiographic loops; b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.

Committee
CLC/TC 62
DevelopmentNote
Supersedes EN 60601-2-51. (10/2015)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current
Supersedes

I.S. EN 740:1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS EN 16372:2014 Aesthetic surgery services
EN 60601-2-47:2015 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
BS 5724-2.204(1999) : 1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
CEI EN 60601-2-27 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
UNE-EN 16372:2015 Aesthetic surgery services
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
I.S. EN 60601-2-27:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
BS EN 740:1999 Anaesthetic workstations and their modules. Particular requirements
EN 16372:2014 Aesthetic surgery services
EN 740:1998/A1:2004 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS EN 60601-2-51:2003 Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
BS EN 60601-2-47:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
BS EN 60601-2-27:2014 Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
I.S. EN 60601-2-51:2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
EN 60601-2-27:2014 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

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

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