IEC 60601-2-25:2011
Current
The latest, up-to-date edition.
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French, Spanish, Castilian
10-19-2011
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) - ELECTRODES, their positions,
identifications and colour codes
Annex CC (informative) - LEADS, their identification and
colour codes (other than those specified in
201.12.4.102)
Annex DD (informative) - Polarity of PATIENT LEADS
(other than those specified in 201.12.4.102)
Annex EE (informative) - Additional marking of ELECTRODES
Annex FF (informative) - Definitions and rules for the
measurement of ELECTROCARDIOGRAMS
Annex GG (informative) - Calibration and test data sets
Annex HH (informative) - CTS test atlas
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are:
a) the part of Medical electrical equipment that provides vectorcardiographic loops;
b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Supersedes IEC 60601-2-51. (10/2011) Stability Date: 2018. (10/2017). This standard was just updated in our system however it was originally released on 10-2011
|
| DocumentType |
Standard
|
| ISBN |
978-2-88912-719-1
|
| Pages |
196
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| VDE 0750-2-25:2016 | Identical |
| NEN EN IEC 60601-2-25 : 2015 | Identical |
| I.S. EN 60601-2-25:2015 | Identical |
| AS/NZS IEC 60601.2.25:2016 | Identical |
| PN EN 60601-2-25 : 2016 | Identical |
| DIN EN 60601-2-25 : 2016 | Identical |
| VDE 0750-2-25 : 2001 | Identical |
| IS 13450 : Part 2 : Sec 25 : 2018 | Identical |
| BS EN 60601-2-25:2015 | Identical |
| UNE-EN 60601-2-25:2016 | Identical |
| CEI EN 60601-2-25 : 2016 | Identical |
| EN 60601-2-25:2015 | Identical |
| JIS T 0601-2-25:2014 | Identical |
| SN EN 60601-2-25:2015 | Identical |
| ANSI/AAMI/IEC 60601-2-25:2011(R2016) | Identical |
| CSA C22.2 No. 601.2.25 : 1994 | Identical |
| AAMI EC11 : 1991 | Identical |
| CSA C22.2 No. 601.2.25A : 2002 | Identical |
| AAMI IEC 60601-2-25 : 2011 | Identical |
| SN EN 60601-2-25 : 1995 AMD 1 1999 | Identical |
| NEN 10601-2-25 : 1996 | Identical |
| BS 5724-2.125(1993) : 1993 AMD 8112 | Identical |
| BS EN 60601-2-51:2003 | Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| PD IEC/TR 60601-4-2:2016 | Medical electrical equipment Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| AAMI IEC 60601-2-47 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| AAMI EC38 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| AAMI IEC 60601-2-27:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| CSA C22.2 No. 60601.2.51 : 2004 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
| EN 60601-2-47:2015 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| EN 60601-2-51:2003 | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| AAMI IEC 60601-2-27:2011(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| 09/30172488 DC : 0 | BS EN 60601-2-26 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| 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) |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| CEI EN 60601-2-27 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| I.S. EN 60601-2-47:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| ISO 11073-91064:2009 | Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography |
| 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 1064:2005 | Health informatics. Standard communication protocol. Computer-assisted electrocardiography |
| IEC TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 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 |
| ANSI/AAMI/IEC 60601-2-47:2012(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| AAMI EC13 : 2002 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| 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 |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. EN 1064:2005 | HEALTH INFORMATICS - STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| EN 1064:2005+A1:2007 | Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| I.S. EN 60601-2-27:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| 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) |
| CSA C22.2 No. 60601.2.27:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING 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 60601-2-47:2012 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| EN 16372:2014 | Aesthetic surgery services |
| 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) |
| CSA C22.2 No. 60601.2.27 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 07/30168606 DC : 0 | BS ISO 11073-91064 - HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 91064: STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| BS EN 60601-2-47:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| BS EN 60601-2-27:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| CSA C22.2 No. 60601.2.27 : 2011 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| I.S. EN 60601-2-51:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
| 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) |
| IEC 60601-2-51:2003 | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| EN 60601-2-27:2014 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| IEC 60601-2-47:2012 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| 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 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.
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.