IEC 60601-2-5:2009

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, PDF 3 Users, PDF 5 Users, PDF 9 Users

Language(s): English - French, Spanish, Castilian

Published date: 30-07-2009

Publisher: International Electrotechnical Committee

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

This Particular Standard specifies requirements and tests for the safety of ultrasonic physiotherapy equipment. It amends and supplements IEC 60601-1 (second edition, 1988) including Amendments 1 and 2, hereinafter referred to as the General Standard. This Particular Standard takes into account IEC 60601-1-2 and IEC 61689.

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Committee	TC 62/SC 62D
Development Note	Also numbered as BIS IS 13450-2-5. (11/2011) Stability Date: 2018. (09/2017)
Document Type	Standard
ISBN
Pages
Published
Publisher	International Electrotechnical Committee
Status	Current
Supersedes	IEC 60601-2-5:2000

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
CSA C22.2 NO. 60601-2-5:11 (R2021)	Identical
BS EN 60601-2-5:2015	Identical
NEN EN IEC 60601-2-5 : 2015	Identical
UNE-EN 60601-2-5:2016	Identical
EN 60601-2-5:2015	Identical
PN EN 60601-2-5 : 2016	Identical
VDE 0750-2-5 : 2016	Identical
IS 13450 : PART 2 : SEC 5 : 2018	Identical
DIN EN 60601-2-5 : 2016	Identical
CEI EN 60601-2-5 : 2016	Identical
NFC 74 306 : 1986	Identical
SN EN 60601-2-5 : 2000	Identical
CSA C22.2 No. 60601.2.5:2011	Identical
CSA C22.2 No. 601.2.5 : 0	Identical
NF EN 60601-2-5 : 2005	Identical
CSA C22.2 No. 60601.2.5 : 2011 : R2016	Identical
UNE 20613-2-5:1990	Identical
BS 5724-2.5:1985	Identical
DIN VDE 0750-208 : 1985	Corresponds
CEI 62-23 : 1ED 1998	Identical
NBN C 74 205 : 1986	Identical
NEN 10601-2-5 : 1986	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

BS EN 60601-2-36:2015	Medical electrical equipment Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
04/30115966 DC : DRAFT JUL 2004
CEI EN 61161 : 2014	ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS
I.S. EN ISO 11073-10406:2012	HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
NF 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
BS EN 62127-1 : 2007	ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ
I.S. EN 60601-2-62:2015	MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
EN 61161:2013	Ultrasonics - Power measurement - Radiation force balances and performance requirements
EN 61689:2013	Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
CEI EN 61689 : 2013	ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ
PD IEC/TS 62462:2017	Ultrasonics. Output test. Guidance for the maintenance of ultrasound physiotherapy systems
BS EN 61689:2013	Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
I.S. EN 62127-1:2007	ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007 (EQV))
I.S. 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
CSA C22.2 No. 60601.2.36 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY
IEC TR 60788:2004	Medical electrical equipment - Glossary of defined terms
ISO/IEEE 11073-10418:2014	Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
BS EN 61161:2013	Ultrasonics. Power measurement. Radiation force balances and performance requirements
PD IEC/TR 60601-4-1:2017	Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
I.S. EN 61689:2013	ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ (IEC 61689:2013 (EQV))
BS EN ISO 11073-10418:2014	Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
I.S. EN 61161:2013	ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS (IEC 61161:2013 (EQV))
IEC TR 60601-4-1:2017	Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
CSA C22.2 No. 60601-2-62 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
BS EN 60601-2-62:2015	Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
PD IEC TR 60788:2004	Medical electrical equipment. Glossary of defined terms
12/30191872 DC : 0	BS EN 60601-2-62 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) SYSTEM
12/30253196 DC : 0	BS EN 60601-2-36 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTRACORPOREALLY INDUCED LITHOTRIPSY
I.S. EN ISO 11073-10418:2014	HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
IEC TS 62462:2007	Ultrasonics - Output Test - Guide for the maintenance of ultrasound physiotherapy systems
IEC 61161:2013	Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 62127-1:2007+AMD1:2013 CSV	Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz
IEC 60601-2-62:2013	Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
ISO/IEEE 11073-10406:2012	Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
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
EN ISO 11073-10406:2012	Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
BS EN ISO 11073-10406:2012	Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
11/30230872 DC : 0	BS EN 61689 - ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ
11/30228497 DC : 0	BS EN 61161 - ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS
UNI EN ISO 11073-10406 : 2013	HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
IEC TR 62649:2010	Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices
EN ISO 11073-10418:2014/AC:2016	Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
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 61689:2013	Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
EN 60601-2-62:2015	Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
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

Standards Referencing This Book - (Show below) - (Hide below)

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
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
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
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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