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 |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| 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 |
| BS EN 60601-2-5:2015 | Identical |
| DIN EN 60601-2-5:2016-08 | Identical |
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