IEC 60601-2-40:2016
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
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18-08-2016
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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 for ME
EQUIPMENT
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 DISTURBANCES - Requirements
and tests
Annexes
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME
SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-40:2016 applies to the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as ME equipment. ME equipment intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators are excluded (covered by IEC 60601-2-10). This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Stability Date: 2020. (08/2016)
|
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN 60601-2-40:2019 | Identical |
| OVE EN 60601-2-40 : 2019 05 01 | Identical |
| EN 60601-2-40:2019 | Identical |
| UNE-EN 60601-2-40:2019 | Identical |
| NEN-EN-IEC 60601-2-40:2019 | Identical |
| PN EN 60601-2-40 : 2019 | Identical |
| VDE 0750-2-40:2019-04 | Identical |
| DIN EN 60601-2-40:2019 | Identical |
| IS 13450 : Part 2 : Sec 40:2020 | Identical |
| AS/NZS IEC 60601.2.40:2022 | Identical |
| EN 60601-2-40:1998 | Identical |
| PN EN 60601-2-40 : 2005 | Identical |
| NF EN 60601-2-40 : 2000 | Identical |
| CEI EN 60601-2-40 : 1999 | Identical |
| DIN EN 60601-2-40 : 1998 | Identical |
| UNE-EN 60601-2-40:1999 | Identical |
| ONORM OVE EN 60601-2-40 : 1998 | Identical |
| I.S. EN 60601-2-40:1999 | Identical |
| SN EN 60601-2-40 : 1998 | Identical |
| VDE 0750-2-40 : 1998 | Identical |
| NEN EN IEC 60601-2-40 : 2003 | Identical |
| I.S. EN 60645-7:2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSES |
| EN 60645-7:2010 | Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses |
| 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 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) |
| UNE-EN 60645-7:2010 | Electroacoustics - Audiometric equipment -- Part 7: Instruments for the measurement of auditory brainstem responses |
| 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 |
| 07/30173584 DC : 0 | BS EN 60645-7 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY EVOKED POTENTIALS |
| 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 |
| IEC 60645-7:2009 | Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| 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) |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 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) |
| BS EN 60645-7:2010 | Electroacoustics. Audiometric equipment Instruments for the measurement of auditory brainstem responses |
| CEI EN 60645-7 : 2013 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSE |
| 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 60601-2-10:2012+AMD1:2016 CSV | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| ISO 15004-2:2007 | Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection |
| IEC 62368-1:2014 | Audio/video, information and communication technology equipment - Part 1: Safety requirements |
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