I.S. EN 60601-2-37:2008
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT
Hardcopy , PDF
English
01-01-2008
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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 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
202.6 ELECTROMAGNETIC COMPATIBILITY
Annex AA (informative) - Guidance and rationale
for particular subclauses
Annex BB (informative) - Guidance in classification
according to CISPR 11
Annex CC (informative) - Guidance to the
MANUFACTURER on the interpretation
of TI and MI to to be used to inform the
OPERATOR
Annex DD (informative) - Example set-up to
measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES
Annex EE (informative) - Acoustic output table intended
for 3rd parties
Bibliography
Index of defined terms
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EC Directives
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
142
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 60601-2-37:2008/A1:2015 | Identical |
| IEC 60601-2-37:2007+AMD1:2015 CSV | Identical |
| IEC 62127-1:2007+AMD1:2013 CSV | Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz |
| ISO/IEC Guide 98:1993 | Guide to the expression of uncertainty in measurement (GUM) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| NEMA UD 3-2004 (R2009) | REAL-TIME DISPLAY OF THERMAL AND MECHANICAL ACOUSTIC OUTPUT INDICES ON DIAGNOSTIC ULTRASOUND EQUIPMENT |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| IEC 61157:2007+AMD1:2013 CSV | Standard means for the reporting of the acoustic output of medicaldiagnostic ultrasonic equipment |
| IEC 62359:2010+AMD1:2017 CSV | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| EN 62127-1:2007/A1:2013 | ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013) |
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