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

This particular standard applies 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. 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;
– ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND
(HITU) and other therapy equipment as described in Annex AA;

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: 16-Aug-2015
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 17-Aug-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
• Ref Project: 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

Relations

• Replaces: SIST EN 60601-2-36:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
• Effective Date: 01-Sep-2015
• Replaces: SIST EN 60601-2-36:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
• Effective Date: 28-Jan-2023
• Replaces: SIST EN 60601-2-36:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-36:2015
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
SIST EN 60601-2-36:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-36:2015

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SIST EN 60601-2-36:2015


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

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SIST EN 60601-2-36:2015
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.
2

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SIST EN 60601-2-36:2015
EN 60601-2-36:2015 (E)
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

3

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SIST EN 60601-2-36:2015
EN 60601-2-36:2015 (E)
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.

4

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SIST EN 60601-2-36:2015



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



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-36:2015
– 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

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SIST EN 60601-2-36:2015
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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-36 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
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 Amendment 1:2012).

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SIST EN 60601-2-36:2015
– 4 – IEC 60601-2-36:2014  IEC 2014
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1109/FDIS 62D/1122/RVD

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

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SIST EN 60601-2-36:2015
IEC 60601-2-36:2014  IEC 2014 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN 60601-2-36:2015
– 6 – IEC 60601-2-36:2014  IEC 2014
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment
for EXTRACORPOREALLY INDUCED LITHOTRIPSY. It amends and supplements IEC 60601-1/A1:2012
(Ed. 3.1): Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance), hereinafter referred to as the general standard.
The aim of this second edition is to bring this particular standard up to date with reference to
the third edition of the general standard through reformatting and technical changes.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. It is considered that knowledge of the reasons for these
requirements will not only facilitate the proper application of the standard but will, in due
course, expedite any revision necessitated by changes in clinical practice or as a result of
developments in technology. However, Annex AA does not form part of the requirements of
this standard.

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SIST EN 60601-2-36:2015
IEC 60601-2-36:2014  IEC 2014 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

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



201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This particular standard applies 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. 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;
– ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND
(HITU) and other therapy equipment as described in Annex AA;
201.1.2 * Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as
defined in 201.3.206 including equipment for other medical applications of therapeutic
extracorporeal focused PRESSURE PULSES.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
2
IEC 60601-1-2:2007 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10
do not apply. All other published collateral standards in the IEC 60601-1 series apply as
published.
—————————
1
The general standard is IEC 60601-1:2005/A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance.
2
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop
controllers

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SIST EN 60601-2-36:2015
– 8 – IEC 60601-2-36:2014  IEC 2014
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement:

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SIST EN 60601-2-36:2015
IEC 60601-2-36:2014  IEC 2014 – 9 –
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
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: Characterization of fields
201.3 Terms and definitions
NOTE An index of defined terms is found beginning on page 20.
For the purpose of this document, the terms and definitions given in IEC 60601-1:2005/A1:2012
apply, except as follows:
Additional definitions:
201.3.201
ENERGY FLUX DENSITY
derived pulse-intensity integral as defined in 3.4 and 7.3.2 of IEC 61846 at the position of the
FOCUS
201.3.202
ENERGY PER PULSE
derived acoustic pulse energy as defined in 7.3.4 of IEC 61846
Note 1 to entry: The temporal integration limits (3.23 of IEC 61846) and the radius R of the chosen circular cross
section area shall be stated in order to allow for proper interpretation of the values.
201.3.203
EXTRACORPOREALLY INDUCED LITHOTRIPSY
LITHOTRIPSY inside the PATIENT by pressure pulses generated outside the PATIENT
201.3.204
FOCAL VOLUME
volume in space contained within the surface defined by the –6 dB isobar of the maximum
peak compressional acoustic pressure
201.3.205
LITHOTRIPSY
comminution or fragmentation of calculi
201.3.206
LITHOTRIPSY EQUIPMENT
ME-EQUIPMENT intended to be used for LITHOTRIPSY treatment
201.3.207
* LOCALIZATION DEVICE
device used to determine the position of the calculi in (three-dimensional) space

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SIST EN 60601-2-36:2015
– 10 – IEC 60601-2-36:2014  IEC 2014
201.3.208
POSITIONING DEVICE
device which brings the calculi into coincidence with the TARGET LOCATION
Note 1 to entry: See also IEC 61846:1998, 3.22, TARGET LOCATION.
201.3.209
PRESSURE PULSE
acoustic wave emitted by the LITHOTRIPSY EQUIPMENT
[SOURCE: IEC 61846, definition 3.18 and Clause C.4]
201.3.210
PRESSURE PULSE COUPLING
any means allowing transition of the PRESSURE PULSE from the ME EQUIPMENT into the PATIENT
201.3.211
TARGET MARKER
marker which is used to indicate the TARGET LOCATION¨
EXAMPLE A marker on the imaging device.
Note 1 to entry: See also IEC 61846:1998, 3.22, TARGET LOCATION.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE
The ME EQUIPMENT shall be free from incorrect display of energy levels (see 201.12.1.102).
The ME EQUIPMENT shall be free from unintended shock wave release (see 201.12.4.6).
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
Safety in SINGLE FAULT CONDITION of the PRESSURE PULSE release (avoiding faulty release) and
safety in SINGLE FAULT CONDITION in motor supported positioning (to avoid unintentional
changes of position during PRESSURE PULSE release and mechanical danger) shall be ensured.
These requirements may be met by mutually interlocking the two systems, e.g. by mutually
interlocking the PRESSURE PULSE release with a SINGLE FAULT CONDITION secured positioning
device, or by mutually interlocking the POSITIONING DEVICE with a SINGLE FAULT CONDITION
secured PRESSURE PULSE release. This mutual interlocking may be overridden by a deliberate
action of the OPERATOR, for example by pressing a separate switch, if the position of the
calculus is monitored.
Compliance is checked by functional testing and fault analysis.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.

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