• There are no items in your cart

I.S. EN 60601-2-5:2015

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)

English

Published date

01-01-2015

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

View more information
US$64.68
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.