IEC 60601-2-27:2011
Current
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Amended by
Available format(s)
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Published date
03-30-2011
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy.
| Committee |
TC 62/SC 62D
|
| DocumentType |
Standard
|
| ISBN |
978-2-88912-430-5
|
| Pages |
158
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| CAN/CSA-C22.2 NO. 60601-2-27:11 (R2021) | Identical |
| NEN EN IEC 60601-2-27 : 2014 | Identical |
| AS/NZS IEC 60601.2.27:2016 | Identical |
| UNE-EN 60601-2-27:2014 | Identical |
| CEI EN 60601-2-27 : 2016 | Identical |
| DIN EN 60601-2-27 : 2015 | Identical |
| NEN 10601-2-27 : 1994 | Identical |
| VDE 0750-2-27 : 2015 | Identical |
| CSA C22.2 No. 60601.2.27:2011 | Identical |
| BS EN 60601-2-27:2014 | Identical |
| EN 60601-2-27:2014 | Identical |
| NF EN 60601 2-27 : 2014 | Identical |
| PNE-FprEN 60601-2-27 | Identical |
| CSA C22.2 No. 60601.2.27 : 2011 : R2016 | Identical |
| AAMI IEC 60601-2-27:2011 | Identical |
| AAMI IEC 60601-2-27:2011(R2016) | Identical |
| PN EN 60601-2-27 : 2014 | Identical |
| UNE-EN 60601-2-27:2006 | Identical |
| CSA C22.2 No. 60601.2.27 : 2011 : INC : COR 1 : 2012 | Identical |
| CSA C22.2 No. 601.2.27 : 1998 | Identical |
| GOST R IEC 60601-2-27 : 2013 | Identical |
| NBN EN 60601 2-27 : 2014 | Identical |
| BS EN 60601-1-2:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests |
| ANSI/AAMI/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 |
| CEI EN 60601-2-49 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| AAMI DF80 : 2003 : R2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| 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 HE75 : 2009(R2013) | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| UNE-EN 60601-2-25:2016 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| EN 60601-2-25:2015 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of 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 60601-2-26:2015 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| 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 60601-2-34:2014 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| NF EN 60601-2-26 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| BS EN 60601-2-25:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographs |
| 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 |
| BS EN 60601-2-26:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electroencephalographs |
| 06/30160373 DC : 0 | BS EN 60601-2-4 ED.3 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| PD IEC/TR 60601-4-4:2017 | Medical electrical equipment Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| I.S. EN 60601-2-26:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| 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 |
| CSA C22.2 No. 60601.2.49 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| DIN EN ISO 18778:2009-08 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| I.S. EN ISO 18778:2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| NF EN ISO 18778 : 2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| BS EN 60601-2-34:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| 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 |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| AAMI EC13 : 2002 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
| AAMI IEC 60601-2-25 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| AAMI DF80:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| BS EN 60601-2-49:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| 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 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 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 |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| EN 60601-2-4:2011 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| UNI EN ISO 18778 : 2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| 12/30159217 DC : 0 | BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| CSA C22.2 No. 60601-2-25 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| CEI EN 60601-2-4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| 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) |
| AAMI IEC 60601-2-4 : 2010 : R2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| IEC 80601-2-49:2018 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| 03/111581 DC : DRAFT JULY 2003 | BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| 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 |
| CSA C22.2 No. 60601.2.49:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| BS EN 60601-2-4:2011 | Medical electrical equipment Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| I.S. EN 60601-2-4:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| I.S. EN 60601-2-49:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| I.S. EN 60601-2-34:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| I.S. EN 60601-2-25:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| ISO 18778:2005 | Respiratory equipment — Infant monitors — Particular requirements |
| BS EN ISO 18778:2009 | Respiratory equipment. Infant monitors. Particular requirements |
| UNE-EN 60601-2-49:2016 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| 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 |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 18778:2009 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| 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 16372:2014 | Aesthetic surgery services |
| ANSI/AAMI/IEC 60601-2-25:2011(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| BS EN 60601-2-47:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| IEC TR 60601-4-4:2017 | Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related 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) |
| BIS IS/ISO 14708-1 : 2000 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| CEI EN 60601-2-26 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| IEC 60601-2-4:2010+AMD1:2018 CSV | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| EN 60601-2-49:2015 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| CSA C22.2 No. 60601.2.26 : 2014(R2018) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIS SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| CSA C22.2 No. 60601.2.4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| CSA C22.2 No. 60601.1.2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| CSA C22.2 No. 60601.2.4 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
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