IEC 60601-2-40:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Hardcopy , PDF
English - French
18-08-2016
20-12-2024
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 |
Superseded
|
| SupersededBy | |
| 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 |
| 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 |
| ABNT NBR IEC 60601-2-40:2019 | Identical |
| CEI EN 60601-2-40 : 2019 | Identical |
| DS/EN 60601-2-40 : 2019 | Identical |
| UNE-EN 60601-2-40:2019 | Identical |
| NBR IEC 60601-2-40 : 1998 | Identical |
| EN 60601-2-40:1998 | Identical |
| DS 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 |
| VDE 0750-2-40 : 1998 | Identical |
| NEN EN IEC 60601-2-40 : 2003 | Identical |
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