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
Current Stage
6060 - Document made available
Due Date
22-May-2015
Completion Date
22-May-2015

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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.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-36:2015
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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.
---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
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.
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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

---------------------- Page: 8 ----------------------
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).
---------------------- Page: 9 ----------------------
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.
---------------------- Page: 10 ----------------------
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.
---------------------- Page: 11 ----------------------
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.
---------------------- Page: 12 ----------------------
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
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.

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.
—————————

The general standard is IEC 60601-1:2005/A1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance.

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
---------------------- Page: 13 ----------------------
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:
---------------------- Page: 14 ----------------------
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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