Medical electrical equipment 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

06-30-2015

Publisher

British Standards Institution

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

Committee	CH/62/4
DevelopmentNote	Supersedes 93/503810 DC. (11/2005) 1997 Edition remains active & will be withdrawn on 22/05/2018. Supersedes 12/30253196 DC. Supersedes BS 5724-2.36(1997) which remains active & will be withdrawn on 22/05/2018. (06/2015)
DocumentType	Standard
Pages	28
PublisherName	British Standards Institution
Status	Current
Supersedes	12/30253196 DC : 0 BS EN 60601-2-36:1997 BS 5724-2.36(1997) : 1997 93/503810 DC : MAY 93

Standards	Relationship
I.S. EN 60601-2-36:2015	Identical
DIN EN 60601-2-36 : 2015	Identical
EN 60601-2-36:2015	Identical
IEC 60601-2-36:2014	Identical
SN EN 60601-2-36 : 1997	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 61689:2013	Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
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
EN 62555:2014	Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
IEC TS 62556:2014	Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems