I.S. EN 60601-2-5:2015
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
Hardcopy , PDF
English
01-01-2015
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National Foreword
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
Annex BB (informative) - Example set-up to measure surface
temperature of externally applied TRANSDUCER
ASSEMBLIES
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 ULTRASONIC PHYSIOTHERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT.
| DevelopmentNote |
Supersedes I.S. HD 395-2-5. (10/2011) 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 |
80
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN 60601-2-5 : 2005 | Identical |
| SN EN 60601-2-5 : 2000 | Identical |
| BS EN 60601-2-5:2015 | Identical |
| DIN EN 60601-2-5 : 2016 | Identical |
| UNE-EN 60601-2-5:2016 | Identical |
| EN 60601-2-5:2015 | Identical |
| IEC 62127-1:2007+AMD1:2013 CSV | Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz |
| ISO/IEC Guide 98:1993 | Guide to the expression of uncertainty in measurement (GUM) |
| IEC 61161:2013 | Ultrasonics - Power measurement - Radiation force balances and performance requirements |
| IEC 61689:2013 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
| IEC 60050-802:2011 | International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics |
| EN 61161:2013 | Ultrasonics - Power measurement - Radiation force balances and performance requirements |
| IEC 60469-1:1987 | Pulse techniques and apparatus. Part 1: Pulse terms and definitions |
| 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 61689:2013 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
| 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 |
| EN 60601-2-36:2015 | Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
| EN 62127-2:2007/A2:2017 | ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ |
| IEC TS 62462:2007 | Ultrasonics - Output Test - Guide for the maintenance of ultrasound physiotherapy systems |
| IEC 62127-2:2007+AMD1:2013+AMD2:2017 CSV | Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz |
| EN 62127-1:2007/A1:2013 | ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013) |
| IEC 60601-2-36:2014 | Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
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