DIN EN 60601-2-51 : 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
01-08-2016
12-01-2013
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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.