14/30281087 DC : 0
NA
Status of Standard is Unknown
BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT
Hardcopy , PDF
English
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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 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 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements
and tests
206 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral Standard: Usability
208 Medical electrical equipment - Part 1-8: General
requirements for safety - Collateral Standard:
General requirements, tests and guidance
for alarm systems in medical electrical equipment
and medical electrical systems
209 Medical electrical equipment - Part 1-9: General
requirements for safety - Collateral Standard:
Requirements for environmentally conscious
design
Annex C (informative) - Guide to marking and labeling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (Normative) - Evaluating me equipment performance
using the phantom
Annex CC (informative) - Reference to the essential principles
Bibliography
Index of defined terms
BS EN 80601-2-71.
| Committee |
CH/62/4
|
| DocumentType |
Draft
|
| Pages |
41
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| 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 |
| 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 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
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