UNE-EN 60601-2-5:2016
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
Spanish, Castilian, English
08-06-2016
FOREWORD
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST THE HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization, disinfection and
compatibility
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
Figure 101
Appendix L
Annex AA - General guidance and rationale
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as ME EQUIPMENT.
Committee |
CTN 209/SC 62
|
DevelopmentNote |
Supersedes UNE 20613-2-5 (10/2003)
|
DocumentType |
Standard
|
Pages |
40
|
PublisherName |
Asociacion Espanola de Normalizacion
|
Status |
Current
|
Supersedes |
Standards | Relationship |
SN EN 60601-2-5 : 2000 | Identical |
BS EN 60601-2-5:2015 | Identical |
EN 60601-2-5:2015 | Identical |
IEC 60601-2-5:2009 | Identical |
NF EN 60601-2-5 : 2005 | Identical |
I.S. EN 60601-2-5:2015 | Identical |
DIN EN 60601-2-5 : 2016 | 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 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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