SIST EN 60601-2-36:1998
(Main)Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
Applies to the safety of equipment for extracorporeally induced lithotripsy, i.e. device for treatment with extracorporally generated pressure pulses. The applicability of this 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.
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Geräten zur extrakorporal induzierten Lithotripsie (IEC 60601-2-36:1997)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité des appareils pour lithotritie créée de façon extra-corporelle (CEI 60601-2-36:1997)
S'applique à la sécurité des appareils pour lithotritie créée de façon extra-corporelle, c'est-à-dire des dispositifs pour la lithotritie à impulsions de pression créées de façon extra-corporelle. La possibilité d'appliquer la présente norme 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.
Medicinska električna oprema - 2. del: Posebne varnostne zahteve za opremo za zunajtelesno inducirano litotripsijo (IEC 60601-2-36:1997)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-36:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]DKWHYH]DRSUHPR]D
]XQDMWHOHVQRLQGXFLUDQROLWRWULSVLMR ,(&
Medical electrical equipment - Part 2: Particular requirements for the safety of equipment
for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
Geräten zur extrakorporal induzierten Lithotripsie (IEC 60601-2-36:1997)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité des appareils pour
lithotritie créée de façon extra-corporelle (CEI 60601-2-36:1997)
Ta slovenski standard je istoveten z: EN 60601-2-36:1997
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-36:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-36:1998
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SIST EN 60601-2-36:1998
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SIST EN 60601-2-36:1998
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SIST EN 60601-2-36:1998
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SIST EN 60601-2-36:1998
NORME
CEI
INTERNATIONALE
IEC
60601-2-36
INTERNATIONAL
Première édition
STANDARD
First edition
1997-03
Appareils électromédicaux –
Partie 2:
Règles particulières de sécurité des appareils
pour lithotritie créée de façon extra-corporelle
Medical electrical equipment –
Part 2:
Particular requirements for the safety of equipment
for extracorporeally induced lithotripsy
IEC 1997 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni utilisée No part of this publication may be reproduced or utilized in
sous quelque forme que ce soit et par aucun procédé, électronique any form or by any means, electronic or mechanical, including
ou mécanique, y compris la photocopie et les microfilms, sans photocopying and microfilm, without permission in writing from
l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE Q
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue
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SIST EN 60601-2-36:1998
60601-2-36 © IEC:1997 – 3 –
CONTENTS
Page
FOREWORD . 5
INTRODUCTION . 7
Clause
SECTION ONE: GENERAL
1 Scope and object. 9
2 Terminology and definitions . 11
6 Identification, marking and documents . 13
SECTION TWO: ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 15
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 17
20 Dielectric strength. 17
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 17
22 Moving parts. 21
24 Stability in NORMAL USE . 23
26 Vibration and noise. 23
28 Suspended masses. 25
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
35 Acoustical energy (including ultrasonics) . 25
36 Electromagnetic compatibility. 25
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures. 27
49 Interruption of the power supply . 27
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data . 27
51 Protection against hazardous output . 29
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
54 General. 29
56 Components and general assembly. 31
57 MAINS PARTS, components and layout . 31
Annexes
L References – Publications mentioned in this Standard . 33
AA General guidance and rationale . 35
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SIST EN 60601-2-36:1998
60601-2-36 © IEC:1997 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of equipment
for extracorporeally induced lithotripsy
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
comprising all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the
form of standards, technical reports or guides and they are accepted by the National Committees in that
sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-36 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/211/FDIS 62D/231/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.
Annex AA is for information only.
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications: in italic type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN
CLAUSE 2 AND IN IEC 601-1: SMALL CAPITALS.
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SIST EN 60601-2-36:1998
60601-2-36 © IEC:1997 – 7 –
INTRODUCTION
This Particular Standard supplements IEC 601-1 (second edition, 1988) Medical electrical
equipment – Part 1: General requirements for safety, and its amendments 1 (1991) and
2 (1995), hereinafter referred to as the General Standard (see 1.3).
The requirements are followed by specifications for the relevant tests.
Following the decision taken by subcommittee 62D at the meeting in Washington in 1979, a
"General guidance and rationale" section giving some explanatory notes, where appropriate,
about the more important requirements is included in annex AA.
Clauses or subclauses for which there are explanatory notes in annex AA are marked with an
asterisk (*).
It is considered that a 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, this annex does not form part of the requirements of this Standard.
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SIST EN 60601-2-36:1998
60601-2-36 © IEC:1997 – 9 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of equipment
for extracorporeally induced lithotripsy
SECTION ONE: GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED
LITHOTRIPSY
as defined in 2.1.101.
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.
While this Particular Standard has been developed for EQUIPMENT intended for use in
LITHOTRIPSY, it has been developed such that, as long as no other specific standards are
available to be used for other medical applications of therapeutic extracorporeal PRESSURE
PULSE equipment, this Standard may be used as a guideline.
1.2 Object
Addition:
This Particular Standard specifies requirements for the safety of EQUIPMENT for EXTRA-
CORPOREALLY INDUCED LITHOTRIPSY.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety, and its amendments 1 (1991) and 2 (1995).
For brevity, Part 1 is referred to in this Particular Standard either as the "General Standard" or
as the "General Requirement(s)".
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to
that of the General Standard. The changes to the text of the General Standard are specified by
the use of the following words:
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SIST EN 60601-2-36:1998
60601-2-36 © IEC:1997 – 11 –
"Replacement" means that the clause or subclause of the General 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.
"Amendment" means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
The term "this Standard" is used to make reference to the General Standard and this Particular
Standard taken together.
The requirements of this Particular Standard take priority over those of the General Standard.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard applies without modification.
Where it is intended that part of the General Standard, although possibly applicable, should not
apply to EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY, this is indicated in this
Particular Standard.
If equipment such as lasers or explosive agents are used for the generation of extracorporeally
induced PRESSURE PULSES, additional reference is made to the applicable Particular Standards.
2 Terminology and definitions
This clause of the General Standard applies except as follows:
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
Additional definition:
2.1.101 EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY
(hereinafter referred to as EQUIPMENT)
Device for treatment with extracorporeally generated PRESSURE PULSES.
2.12 Miscellaneous
Additional definitions:
2.12.101 LITHOTRIPSY
Comminution or fragmentation of calculi.
2.12.102 EXTRACORPOREALLY INDUCED LITHOTRIPSY
LITHOTRIPSY inside the PATIENT by PRESSURE PULSES generated outside the PATIENT.
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SIST EN 60601-2-36:1998
60601-2-36 © IEC:1997 – 13 –
2.12.103 PRESSURE PULSE
Acoustic wave emitted by the LITHOTRIPSY EQUIPMENT.
2.12.104 PRESSURE PULSE COUPLING
Any means allowing transition of the PRESSURE PULSE from the EQUIPMENT into the PATIENT.
2.12.105 FOCAL VOLUME
Volume in space contained within the surface defined by the –6 dB isobar of the maximum
peak compressional acoustic pressure.
* 2.12.106 LOCALIZATION DEVICE
Device used to determine the position of the calculi in (three-dimensional) space.
2.12.107 TARGET LOCATION
Location in space where the MANUFACTURER intends the OPERATOR to locate the calculi.
2.12.108 POSITIONING DEVICE
Device which brings the calculi into coincidence with the TARGET LOCATION.
2.12.109 TARGET MARKER
Marker which is used to indicate the TARGET LOCATION.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.3 Marking of controls and instruments
Additional subclause:
6.3.101 Wireless remote control
If the EQUIPMENT is provided with a wireless remote control device, such device shall be clearly
marked as to its purpose and function.
6.8 ACCOMPANYING DOCUMENTS
6.8.2
Instructions for use
*6.8.2 a) General information
Addition:
• Time intervals for maintenance purposes need not be specified in the instructions for use
if indication means (e.g. discharge counter) are provided on the EQUIPMENT and the purpose
of these indication means is explained in the instructions for use.
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SIST EN 60601-2-36:1998
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• In particular, advice, when appropriate, shall be given on the following:
1) Description of the relevant safety precautions to be used to avoid SAFETY HAZARDS,
e.g. the danger resulting from delivering PRESSURE PULSES to organs which contain gas.
2) Caution that PRESSURE PULSES may cause unwanted cardiac activity.
3) When using ECG monitoring equipment to trigger the generation of the PRESSURE
PULSE, only those ECG monitors specified by the MANUFACTURER of the EQUIPMENT shall
be used.
4) Caution that the OPERATOR shall check the position of the calculi as often as
necessary to ensure proper treatment.
* 5) Description of the schedule and measures to be performed within the scope of a
regular performance check.
6) Description concerning the correct use of the PRESSURE PULSE COUPLING including a
reminder that it shall be free of bubbles.
7) Reminder that the PRESSURE PULSE is attenuated during passage through tissue, and
that additional energy is absorbed by bone.
8) Reminder that, even if anti-collision devices are installed, the OPERATOR shall always
watch for any movements that may cause danger to the PATIENT or OPERATOR.
* 6.8.3 Technical description
Addition:
The minimum technical description of the EQUIPMENT should contain, for example:
a) positional precision of the TARGET MARKER with respect to the TARGET LOCATION;
b) position and size of the FOCAL VOLUME with respect to the TARGET LOCATION;
c) peak compressional and rarefactional acoustic pressures;
d) energy per pulse.
SECTION TWO: ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply except as follows:
10 Environmental c
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