EN 60601-2-3:2015/A1:2016
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT (IEC 60601-2-3:2012/A1:2016)
30-09-2016
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 for ME EQUIPMENT
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
Annexes
ANNEX C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Index of defined terms used in this particular standard
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
Describes the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, as defined in subclause 201.3.206.
| Committee |
TC 62
|
| DevelopmentNote |
Supersedes HD 395.2.3. (05/2001)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN 10601-2-3 : 1993 | Identical |
| NBN EN 60601 2-3 : 2015 AMD 1 2016 | Identical |
| UNE-EN 60601-2-3:2015/A1:2016 | Identical |
| UNE-EN 60601-2-3:1996 | Identical |
| PN EN 60601-2-3 : 2015 AMD 1 2016 | Identical |
| SN EN 60601-2-3:2015 | Identical |
| I.S. EN 60601-2-3:2015 | Identical |
| CEI EN 60601-2-3 : 2016 | Identical |
| IEC 60601-2-3:2012+AMD1:2016 CSV | Identical |
| NEN EN IEC 60601-2-3 : 2015 AMD 1 2016 | Identical |
| VDE 0750-2-3 : 2017 | Identical |
| NF EN 60601 2-3 : 2015 AMD 1 2016 | Identical |
| BS EN 60601-2-3:2015 | Identical |
| DIN EN 60601-2-3 : 2017 | Identical |
| PNE-EN 60601-2-3:2012/FprA1 | Identical |
| BS EN 60601-2-3:2015+A1:2016 | Identical |
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