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UNE-EN 60601-2-5:2016

Current

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

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

08-06-2016

€93.60
Excluding VAT

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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