15/30287154 DC : 0
NA
Status of Standard is Unknown
BS EN 60601-2-40 ED 2.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT - PROPOSED HORIZONTAL STANDARD
Hardcopy , PDF
English
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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 form 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 MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General
requirements for basic safety and essential
performance - collateral standard: Electromagnetic
disturbances - Requirements and tests
202.8 Electromagnetic IMMUNITY requirements for ME
EQUIPMENT and ME SYSTEMS
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
BS EN 60601-2-40 ED 2.0.
| Committee |
CH/62/4
|
| DocumentType |
Draft
|
| Pages |
32
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
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| ISO 15004-2:2007 | Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection |
| IEC 60318-1:2009 | Electroacoustics - Simulators of human head and ear - Part 1: Ear simulator for the measurement of supra-aural and circumaural earphones |
| IEC 62368-1:2014 | Audio/video, information and communication technology equipment - Part 1: Safety requirements |
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