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
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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
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.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Also numbered as BIS IS 13450-2-5. (11/2011) Stability Date: 2018. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
66
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | 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 |
| 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 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 |
| 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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