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BS EN 60601-2-37 : 2008

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2008

INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terminology 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.

Committee
CH/62/2
DevelopmentNote
Supersedes 99/565698 DC. (07/2002) Supersedes 05/30130926 DC. (05/2006) Supersedes 06/30139700 DC. (08/2008) 2008 Version remains current. (04/2012) Supersedes 12/30256177 DC. 2008 Edition Re-Issued in September 2015 & incorporates AMD 1 2015. 2008 + A11 2011 Edition remains current and will be withdrawn on 13/07/2018.(03/2017)
DocumentType
Standard
Pages
52
PublisherName
British Standards Institution
Status
Current
Supersedes

IEC 62127-1:2007+AMD1:2013 CSV Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz
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
EN 61157:2007/A1:2013 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT (IEC 61157:2007/A1:2013)
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
OIML G 1-100 : 2008 EVALUATION OF MEASUREMENT DATA - GUIDE TO THE EXPRESSION OF UNCERTAINTY IN MEASUREMENT
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 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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)
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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