EN 60601-2-51:2003

Superseded

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

Superseded date

10-01-2015

Published date

07-31-2003

Publisher

European Committee for Standards - Electrical

INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
                OR EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
                FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                AND OTHER SAFETY HAZARDS
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
   50.101 Automated measurements on ECGs (for ANALYSING
          ELECTROCARDIOGRAPHS)
   50.102 Automated ECG interpretation (for ANALYSING
          ELECTROCARDIOGRAPHS)
51 Protection against hazardous output
   51.101 LEADS
   51.102 Input circuit
   51.103 CALIBRATION
   51.104 SENSITIVITY
   51.105 Reduction of the effects of unwanted external
          voltages
   51.106 Base-line
   51.107 Distortion
   51.108 Printing, electronic storage and transmission
   51.109 Use with cardiac pacemakers
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
   56.7 BATTERIES
Appendix L (normative) References - Publications
           mentioned in this standard
Annex AA (informative) General guidance and rationale
Annex BB (informative) ELECTRODES, their positions,
         identifications and colour codes
Annex CC (informative) LEADS and their identification
         (other than described in 51.101)
Annex DD (informative) Polarity of PATIENT LEADS
         (other than those specified in 51.101)
Annex EE (informative) Additional marking of electrodes
Annex FF (informative) Noise
Annex GG (normative) Definitions and rules for the
         measurement of ELECTROCARDIOGRAMS
Annex HH (normative) Calibration and test data sets
Annex II (informative) CTS test atlas
Annex ZA (normative) Normative references to international
         publications with their corresponding European
         publications
Annex ZB (normative) Other international publications mentioned in
         this standard with the reference of the relevant European
         publications
Bibliography
INDEX OF DEFINED TERMS
Figures
Tables

Establishes particular requirements, in addition to the requirements of EN 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particularly to - recording electrocardiographs; - electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes; - electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit; - analysing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG; - those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analysing electrocardiographs.

Committee	CLC/TC 62
DocumentType	Standard
PublisherName	European Committee for Standards - Electrical
Status	Superseded
SupersededBy	EN 60601-2-25:2015

Standards	Relationship
IEC 60601-2-51:2003	Identical
NBN EN 60601-2-51 : 2004	Identical
NEN EN IEC 60601-2-51 : 2003	Identical
I.S. EN 60601-2-51:2003	Identical
PN EN 60601-2-51 : 2005	Identical
SN EN 60601-2-51 : 2003	Identical
UNI CEI EN 60601-2-52 : 2010	Identical
DIN EN 60601-2-51 : 2004	Identical
VDE 0750-2-51 : 2004	Identical
BS EN 60601-2-51:2003	Identical
UNE-EN 60601-2-51:2005	Identical
CEI EN 60601-2-51 : 2005	Identical
NF EN 60601-2-51 : 2005	Identical

AAMI EC11 : 1991	DIAGNOSTIC ELECTROCARDIOGRAPHIC DEVICES
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-2-25:2015	Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
ENV 1064 : 1994	MEDICAL INFORMATICS - STANDARD COMMUNICATION PROTOCOL - COMPUTER ASSISTED ELECTROCARDIOGRAPHY
IEC 60601-2-25:2011	Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
EN 60601-1-4:1996/A1:1999	MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
IEC 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems