I.S. EN 60601-2-51:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
10-11-2015
English
01-01-2003
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FOREWORD
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
Annex DD (informative) Polarity of PATIENT LEADS
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
Bibliography
INDEX OF DEFINED TERMS
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.
| DocumentType |
Standard
|
| Pages |
96
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 60601-2-51 : 2005 | Identical |
| UNE-EN 60601-2-51:2005 | Identical |
| SN EN 60601-2-51 : 2003 | Identical |
| BS EN 60601-2-51:2003 | Identical |
| EN 60601-2-51:2003 | Identical |
| NBN EN 60601-2-51 : 2004 | Identical |
| IEC 60601-2-51:2003 | Identical |
| DIN EN 60601-2-51 : 2004 | 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 |
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