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I.S. EN 60601-2-36:2015

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 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) - Definition of coordinates, FOCUS
         and TARGET LOCATION
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

Pertains to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES, hereafter 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
54
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
DIN EN 60601-2-36 : 2015 Identical
EN 60601-2-36:2015 Identical
SN EN 60601-2-36 : 1997 Identical
BS EN 60601-2-36:2015 Identical
UNE-EN 60601-2-36:1998 Identical

EN 10002-1 : 2001 METALLIC MATERIALS - TENSILE TESTING - PART 1: METHOD OF TEST AT AMBIENT TEMPERATURE
IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
IEC 61846:1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
IEC 62555:2013 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
EN 61846:1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
IEC 60601-2-62:2013 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
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
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
DIN 50100:2015-11 (Draft) LOAD CONTROLLED FATIGUE TESTING - EXECUTION AND EVALUATION OF CYCLIC TESTS AT CONSTANT LOAD AMPLITUDES ON METALLIC SPECIMENS AND COMPONENTS
IEC TS 62556:2014 Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems

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