I.S. EN 60601-2-47:2015
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS
Hardcopy , PDF
English
01-01-2015
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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
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
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
148
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN 60601-2-47 : 2016 | Identical |
| EN 60601-2-47:2015 | Identical |
| BS EN 60601-2-47:2015 | Identical |
| UNE-EN 60601-2-47:2002 | Identical |
| 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 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
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