CEI EN 60601-2-62 : 2016
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
Hardcopy , PDF
English
01-01-2016
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 compatibility - Requirements
and tests
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Targeting
Annex CC (informative) - HITU - specific risks
Annex DD (informative) - Determining regions of HITU
fields for measurement
Annex EE (informative) - Guidance in classification
according to CISPR 11
Annex FF (informative) - Notes on using a saline or
water bath for EMI testing
Bibliography
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EU Directives
This International Standard applies to the basic safety and essential performance of high-intensity therapeutic ultrasound equipment.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-239. (02/2016)
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| IEC 60601-2-62:2013 | Identical |
| EN 60601-2-62:2015 | Identical |
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