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DIN EN 60601-2-51 : 2004

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS

Superseded date

01-08-2016

Superseded by

DIN EN 60601-2-25 : 2016

Published date

12-01-2013

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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

Describes 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.

DevelopmentNote
A transition period, as set out in DIN EN 60601-2-25 issue 08-2016, exists until 15-09-2018. (08/2016)
DocumentType
Standard
PublisherName
Verband Deutscher Elektrotechniker
Status
Superseded
SupersededBy

Standards Relationship
BS EN 60601-2-51:2003 Identical
SN EN 60601-2-51 : 2003 Identical
EN 60601-2-51:2003 Identical
VDE 0750-2-51 : 2004 Identical
UNE-EN 60601-2-51:2005 Identical
IEC 60601-2-51:2003 Identical
I.S. EN 60601-2-51:2003 Identical

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