EN 60601-2-36:2015

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

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.

Medizinische elektrische Geräte - Teil 2-36: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten zur extrakorporal induzierten Lithotripsie

Appareils électromédicaux - Partie 2-36: Exigences particulières pour la sécurité de base et les performances essentielles des appareils pour lithotritie créée de façon extracorporelle

L'IEC 60601-2-36:2014 s'applique à la sécurité de base et aux performances essentielles des appareils pour lithotritie créée de façon extracorporelle, y compris des appareils pour d'autres applications médicales des impulsions de pression focalisées thérapeutiques créées de façon extracorporelle. La possibilité d'appliquer la présente norme particulière est limitée aux éléments directement en cause dans le traitement par lithotritie tels que, sans être exclusif, le générateur d'impulsions de pression, le dispositif supportant le patient, et leurs interactions avec les dispositifs d'imagerie et de surveillance. D'autres dispositifs, tels que les calculateurs organisant le traitement du patient, les dispositifs à rayonnement X et à ultrasons, sont exclus de la présente norme, car ils font l'objet d'autres normes IEC applicables. La présente norme particulière ne s'applique pas aux appareils à ultrasons prévus pour être utilisés en physiothérapie; et aux appareils à ultrasons prévus pour être utilisés en thérapie HITU (ultrasonore thérapeutique de haute intensité) et autres appareils de thérapie décrits à l'Annexe AA. Cette deuxième édition annule et remplace la première édition de l'IEC 60601-2-36 parue en 1997. Cette édition constitue une révision technique et s'aligne structurellement avec l'IEC 60601-1:2005 et son Amendement 1:2012.

Medicinska električna oprema - 2-36. del: Posebne zahteve za osnovno varnost in bistvene lastnosti pri zunajtelesni litotripsiji

Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI opreme za ZUNAJTELESNO LITOTRIPSIJO, kot je opredeljena v točki 201.3.206, vključno z opremo za medicinsko uporabo terapevtskih zunajtelesno induciranih osredotočenih UDARNIH VALOV, v nadaljevanju ELEKTROMEDICINSKA OPREMA. Uporabnost tega standarda je omejena na komponente, ki so neposredno povezani z zdravljenjem LITOTRIPSIJE, kot so med drugim generator UDARNIH VALOV, naprava za podporo PACIENTU in njihove interakcije z napravami za slikanje in nadzor. Druge naprave, kot na primer računalniki za načrtovanje zdravljenja PACIENTA ter rentgenske in ultrazvočne naprave, ne spadajo v področje uporabe tega standarda, ker so obravnavane v drugih uporabljenih standardih IEC.
Ta standard se ne uporablja za:
– ULTRAZVOČNO FIZIOTERAPEVTSKO OPREMO, namenjeno za fizioterapijo;
– ULTRAZVOČNO opremo za visokointenzivne terapevtske ULTRAZVOČNE naprave (HITU) in drugo terapevtsko opremo, opisano v dodatku AA;

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 21-May-2018
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-36:2015 - Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy

Relations

• Replaces: EN 60601-2-36:1997 - Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60601-2-36:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLSUL]XQDMWHOHVQLOLWRWULSVLML
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and
essential performance of extracorporeally induced lithotripsy
Medizinische elektrische Geräte - Teil 2-36: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten zur extrakorporal
induzierten Lithotripsie
Appareils électromédicaux - Partie 2-36: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils pour lithotritie créée de façon
extracorporelle
Ta slovenski standard je istoveten z: EN 60601-2-36:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-36

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.01 Supersedes EN 60601-2-36:1997
English Version
Medical electrical equipment - Part 2-36: Particular requirements
for the basic safety and essential performance of equipment for
extracorporeally induced lithotripsy
(IEC 60601-2-36:2014)
Appareils électromédicaux - Partie 2-36: Exigences Medizinische elektrische Geräte - Teil 2-36: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils pour lithotritie créée de façon wesentlichen Leistungsmerkmal von Geräten zur
extracorporelle extrakorporal induzierten Lithotripsie
(IEC 60601-2-36:2014) (IEC 60601-2-36:2014)
This European Standard was approved by CENELEC on 2014-05-15. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-36:2015 E
Foreword
The text of document 62D/1109/FDIS, future edition 2 of IEC 60601-2-36, prepared by IEC/SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-36:2015.
The following dates are fixed:
(dop) 2015-11-22
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-22
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-36:1997.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 60601-2-36:2014 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 61689:2013 NOTE  Harmonized as EN 61689:2013 (not modified).
IEC 62555 NOTE  Harmonized as EN 62555.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Replacement:
IEC 60601-1-2 2007 Medical electrical equipment -- Part 1-2: EN 60601-1-2 2007
(mod) General requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
+AC 2010
Addition:
IEC 60601-1 2005 Medical electrical equipment -- Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+AC 2010
+AC 2014
+A11 2011
+A1 2012  +A1 2013
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 61846 1998 Ultrasonics - Pressure pulse lithotripters - EN 61846 1998
Characteristics of fields
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the
European Commission and the European Free Trade Association, and within its scope the
Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of
14 June 1993 concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling
within the scope of this standard.

IEC 60601-2-36 ®
Edition 2.0 2014-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-36: Particular requirements for the basic safety and essential performance

of equipment for extracorporeally induced lithotripsy

Appareils électromédicaux –
Partie 2-36: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils pour lithotritie créée de façon extracorporelle

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 11.040.01 ISBN 978-2-8322-1498-5

– 2 – IEC 60601-2-36:2014  IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 13
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 15
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 15
202 * ELECTROMAGNETIC COMPATIBILITY – Requirements and tests . 15
Annexes . 15
Annex AA (informative) Particular guidance and rationale . 16
Annex BB (informative) Definition of coordinates, FOCUS and TARGET LOCATION . 17
Bibliography . 18
Index of defined terms used in this particular standard . 20

Figure BB.1 – Geometrical FOCUS distribution . 17

IEC 60601-2-36:2014  IEC 2014 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-36: Particular requirements for the basic safety and essential
performance of equipment for extracorporeally induced lithotripsy

FOREWORD
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