SIST EN 60601-2-11:1998
(Main)Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)
Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)
This standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system. Applies to equipment which is intended to deliver a gamma radiation beam(s) at normal treatment distances greater than 5 cm using a sealed radioactive source(s). Establishes requirements to ensure the radiation safety and enhance the electrical and mechanical safety of gamma beam therapy equipment used in human medical practice and specifies tests for demonstrating compliance with those requirements.
Medizinische elektrische Geräte - Teil 2-11: Besondere Festlegungen für die Strahlensicherheit von Gamma-Bestrahlungseinrichtungen (IEC 60601-2-11:1997)
Appareils électromédicaux - Partie 2-11: Règles particulières de sécurité pour les appareils de gammathérapie (IEC 60601-2-11:1997)
Cette norme spécifie des prescriptions de sécurité pour les appareils de gammathérapie utilisés à des fins de médecine humaine en radiothérapie et s'applique également aux appareils pour lesquels la sélection et l'affichage des paramètres de fonctionnement peuvent être contrôlés par des systèmes électroniques programmables. S'applique à tout appareil destiné à délivrer un ou des faisceaux de rayonnement gamma à des distances normales de traitement supérieures à 5 cm et utilisant une ou plusieurs sources radioactives scellées. Fixe pour les appareils de gammathérapie utilisés en médecine humaine des prescriptions pour assurer la protection contre le rayonnement ainsi qu'un niveau amélioré de sécurité électrique et mécanique. Spécifie des essais pour démontrer la conformité à ces prescriptions.
Medicinska električna oprema - 2-11. del: Posebne varnostne zahteve za opremo za terapijo z gama žarki (IEC 60601-2-11:1997)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-11:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]DKWHYH]DRSUHPR
]DWHUDSLMR]JDPDåDUNL ,(&
Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma
beam therapy equipment (IEC 60601-2-11:1997)
Medizinische elektrische Geräte - Teil 2-11: Besondere Festlegungen für die
Strahlensicherheit von Gamma-Bestrahlungseinrichtungen (IEC 60601-2-11:1997)
Appareils électromédicaux - Partie 2-11: Règles particulières de sécurité pour les
appareils de gammathérapie (IEC 60601-2-11:1997)
Ta slovenski standard je istoveten z: EN 60601-2-11:1997
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.60 Terapevtska oprema Therapy equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-11:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-11:1998
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SIST EN 60601-2-11:1998
NORME
CEI
INTERNATIONALE
IEC
60601-2-11
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
1997-08
Appareils électromédicaux –
Partie 2:
Règles particulières de sécurité
pour les appareils de gammathérapie
Medical electrical equipment –
Part 2:
Particular requirements for the safety
of gamma beam therapy equipment
IEC 1997 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
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procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from 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
X
PRICE CODE
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue
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SIST EN 60601-2-11:1998
60601-2-11 © IEC:1997 – 3 –
CONTENTS
Page
FOREWORD . 9
INTRODUCTION. 11
Clause
SECTION ONE – GENERAL
1 Scope and object. 13
2 Terminology and definitions . 17
4 General requirements for tests. 19
5 Classification . 23
6 Identification, marking and documents. 25
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .31
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 ENCLOSURES and PROTECTIVE COVERS . 33
18 Protective earthing, functional earthing and potential equalization . 33
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 33
20 Dielectric strength. 35
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 35
22 Moving parts. 37
27 Pneumatic and hydraulic power . 39
28 Suspended masses. 39
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SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 RADIATION safety requirements . 41
29.1 Protection of the PATIENT against incorrect ABSORBED DOSE
in the TREATMENT VOLUME. 41
29.1.1 SOURCE CARRIER or SHUTTER . 41
29.1.2 BEAM OFF and BEAM ON conditions . 45
29.1.3 Control of IRRADIATION . 45
29.1.4 STATIONARY RADIOTHERAPY and MOVING BEAM RADIOTHERAPY . 51
29.1.5 Beam distributing systems. 53
29.1.6 WEDGE FILTERS . 55
29.1.7 BEAM APPLICATORS. 57
29.1.8 Facilities for starting IRRADIATION. 57
29.1.9 Facilities for INTERRUPTION OF IRRADIATION . 57
29.1.10 Facilities for TERMINATION OF IRRADIATION . 59
29.1.11 Unplanned TERMINATION OF IRRADIATION. 59
29.1.12 Facilities for checking INTERLOCK systems . 61
29.2 Protection of the PATIENT against STRAY RADIATION in the RADIATION BEAM. 63
29.2.1 RELATIVE SURFACE DOSE . 63
29.3 Protection of the PATIENT against RADIATION outside the RADIATION BEAM. 65
29.3.1 LEAKAGE RADIATION through BEAM LIMITING DEVICES
during IRRADIATION . 65
EAKAGE RADIATION RADIATION BEAM
29.3.2 L outside the maximum . 67
29.4 RADIATION safety for persons other than PATIENTS . 69
29.4.1 Indication of BEAM OFF and BEAM ON conditions. 69
29.4.2 STRAY RADIATION in the BEAM OFF condition . 71
29.4.3 Safety in setting operating states. 73
29.4.4 RADIATION SOURCE and RADIATION HEAD . 73
29.4.5 Radioactive materials used in the construction of the EQUIPMENT. 75
29.4.6 Environmental protection. 77
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
SECTION EIGHT – ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
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SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
57 MAINS PARTS, components and layout. 79
Figures
101 LEAKAGE RADIATION. 81
102 The 16 measurement points of the average LEAKAGE RADIATION. 83
103 Test plane orthogonal to the RADIATION BEAM AXIS at the NORMAL TREATMENT DISTANCE. 85
104 Location of test points for SITE TEST of item a) 2) of 29.3.2. 87
Appendix/Annex
L References – Publications mentioned in this standard . 89
AA Index of terms . 91
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
_________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety
of gamma beam therapy equipment
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 60601-2-11 has been prepared by subcommittee 62C: High energy
radiation equipment and equipment for nuclear medicine, of IEC technical committee 62:
Electrical equipment in medical practice.
The second edition cancels and replaces the first edition published in 1987, amendment 1
(1988) and amendment 2 (1993).
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62C/173/FDIS 62C/192/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 60601-1 OR IEC 60788: SMALL CAPITALS.
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INTRODUCTION
The use of GAMMA BEAM THERAPY EQUIPMENT for RADIOTHERAPY purposes may expose PATIENTS
to danger if the EQUIPMENT fails to deliver the required dose to the PATIENT, or if the EQUIPMENT
design does not satisfy standards of electrical and mechanical safety. The EQUIPMENT may also
cause danger to persons in the vicinity if the EQUIPMENT itself fails to contain the RADIATION
adequately and/or if there are inadequacies in the design of the TREATMENT ROOM.
This Particular Standard establishes requirements to be complied with by MANUFACTURERS in
the design and construction of GAMMA BEAM THERAPY EQUIPMENT. Clause 29 states tolerance
limits beyond which INTERLOCKS must prevent, INTERRUPT or TERMINATE IRRADIATION in order to
avoid an unsafe condition. TYPE TESTS which are performed by the MANUFACTURER, and/or SITE
TESTS, which are not necessarily performed by the MANUFACTURER, are specified for each
requirement.
Clause 29 does not attempt to define the optimum performance requirements for a GAMMA
BEAM THERAPY EQUIPMENT for use in RADIOTHERAPY. Its purpose is to identify those features of
design which are regarded at the present time as essential for the safe operation of such
EQUIPMENT. It places limits on the degradation of EQUIPMENT performance at which it can be
presumed that a fault condition applies, e.g. a component failure, and where an INTERLOCK then
operates to prevent continued operation of the EQUIPMENT.
It should be understood that, before installation, a MANUFACTURER can provide a compliance
certificate relating only to TYPE TESTS. Data available from SITE TESTS should be incorporated in
the ACCOMPANYING DOCUMENTS SITE TEST
, in the form of a report, by those who test the
EQUIPMENT after installation.
The relationship of this Particular Standard with IEC 60601-1 (including the amendments) and
the Collateral Standards is explained in 1.3.
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MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety
of gamma beam therapy equipment
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:
aa)
This Particular Standard specifies requirements for the safety of GAMMA BEAM THERAPY
EQUIPMENT intended for RADIOTHERAPY in human medical practice and includes EQUIPMENT in
which the selection and DISPLAY of operating parameters can be controlled by a PROGRAMMABLE
ELECTRONIC SYSTEM (PES).
bb)
This Particular Standard applies to EQUIPMENT which is intended to deliver a GAMMA RADIATION
BEAM(S) at NORMAL TREATMENT DISTANCES greater than 5 cm using a SEALED RADIOACTIVE
SOURCE(S). For EQUIPMENT operating at shorter distances, special precautions may be
necessary.
cc)
This Particular Standard applies to EQUIPMENT intended to be:
– used under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS
having the skills required for a particular medical application and acting in accordance with
the INSTRUCTIONS FOR USE,
– maintained at predetermined intervals,
– subject to regular checks by the USER,
– used for particular specified clinical purposes e.g. STATIONARY RADIOTHERAPY or MOVING
BEAM RADIOTHERAPY.
dd)
This Particular Standard is applicable to the manufacture and some installation aspects of
GAMMA BEAM THERAPY EQUIPMENT by the inclusion of TYPE TESTS and SITE TESTS respectively.
ee)
This Particular Standard specifies the requirements for EQUIPMENT. It does not specify the
requirements for the RADIATION SOURCES.
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1.2 Object
Addition:
aa)
This Particular Standard establishes requirements to ensure the RADIATION safety and enhance
the electrical and mechanical safety of GAMMA BEAM THERAPY EQUIPMENT used in human
medical practice and specifies tests for demonstrating compliance with those requirements.
bb)
)
1
EQUIPMENT ABSORBED DOSE
In of the type covered by this Standard, is controlled by the time
of IRRADIATION. Tolerances for other methods of controlling the ABSORBED DOSE are not
included in this Standard.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements IEC 60601-1: 1988, Medical electrical
equipment – Part 1: General requirements for safety and amendments 1 (1991) and 2 (1995).
IEC 60601-1 is referred to as the General Standard. As in the General Standard, the
requirements are followed by compliance tests. The term "this Standard" is used to make
reference to the General Standard and this Particular Standard taken together.
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:
"Replacement" means that the clause or subclause of the General Standard is replaced com-
pletely 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.
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.
This Standard is to be read in conjunction with the collateral Standard IEC 60601-1-2 (1993):
Electromagnetic compatibility. No other collateral Standards apply.
Where it is intended that any part of the General Standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this Particular Standard.
——————
)
1
In this Particular Standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water at the depth of maximum
BUILD UP.
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A requirement of this Particular Standard replacing or modifying requirements of the General
Standard takes precedence over these requirements.
2 Terminology and definitions
Addition:
NOTE – Annex AA lists defined terms alphabetically with their source references.
Additional definitions:
2.101 BEAM OFF: The condition in which the RADIATION SOURCE is fully shielded, and is also in
a position in which it can be secured.
2.102 BEAM ON: The condition in which the RADIATION SOURCE is fully exposed for
RADIOTHERAPY.
2.103 CONTROLLING TIMER (abbreviation: TIMER): Device to measure the time during which
IRRADIATION occurs and, when a predetermined time is reached, to TERMINATE IRRADIATION.
2.104 FIELD SIZE: Abbreviation for IRRADIATION FIELD SIZE.
2.105 GANTRY: That part of the EQUIPMENT supporting and allowing possible movements of
the RADIATION HEAD.
2.106 GEOMETRICAL FIELD SIZE: Geometrical projection of the distal end of the BEAM LIMITING
DEVICE on a plane orthogonal to the RADIATION BEAM AXIS, as seen from the centre of the front
surface of the RADIATION SOURCE. The RADIATION FIELD is thus of the same shape as the
aperture of the BEAM LIMITING DEVICE. The GEOMETRICAL FIELD SIZE may be defined at any
distance from the RADIATION SOURCE.
2.107 INTERRUPTION (OF IRRADIATION)/TO INTERRUPT (IRRADIATION): Stopping of/to stop
IRRADIATION and movements with the possibility of continuing without reselecting operating
conditions (i.e. a return to the READY STATE).
2.108 NORMAL TREATMENT DISTANCE: A specified distance measured along the RADIATION BEAM
AXIS from the RADIATION SOURCE to the ISOCENTRE or, for EQUIPMENT without an ISOCENTRE, to a
specified plane.
2.109 PRIMARY/SECONDARY (TIMER) COMBINATION: Combination of two TIMERS in which one is
arranged to be the PRIMARY TIMER and the other is to be the SECONDARY TIMER.
2.110 PRIMARY TIMER: The CONTROLLING TIMER which is intended to TERMINATE IRRADIATION at
the preselected time.
2.111 PROGRAMMABLE ELECTRONIC SYSTEM (abbreviation: PES): Term used to cover systems
incorporating a wide range of programmable devices including microprocessors, programmable
controllers, programmable logic controllers and other computer based devices. These devices
may contain one or more central processing units connected to sensors and/or actuators, for
the purpose of control, protection or monitoring.
2.112 QUALIFIED PERSON: Person recognised by a competent authority as having the requisite
knowledge and training to perform specified duties.
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2.113 REDUNDANT (TIMER) COMBINATION: Combination of two CONTROLLING TIMERS in which
both are arranged to TERMINATE IRRADIATION at the preselected time.
2.114 RELATIVE SURFACE DOSE: Ratio of the ABSORBED DOSE on the RADIATION BEAM AXIS at the
depth of 0,5 mm to the maximum ABSORBED DOSE on the RADIATION BEAM AXIS, both measured
in a PHANTOM with its surface at a specified distance.
2.115 SECONDARY TIMER: The CONTROLLING TIMER which is intended to TERMINATE IRRADIATION
in the event of failure of the PRIMARY TIMER.
2.116 SITE TEST: After installation, test of the individual device or EQUIPMENT to establish
compliance with specified criteria.
2.117 TERMINATION (OF IRRADIATION)/TO TERMINATE (IRRADIATION): Stopping of/to stop
IRRADIATION with no possibility of re-starting without the re-selection of all operating conditions,
(i.e. returning/to return to the PREPARATORY STATE):
– when the preselected value of elapsed time is reached;
or:
– by deliberate manual act;
– by the operation of an INTERLOCK;
– by preselected value of GANTRY angular position in MOVING BEAM RADIOTHERAPY.
2.118 TREATMENT: The application of a prescribed procedure, or a part thereof, for
therapeutic purposes.
2.119 TREATMENT FIELD: In RADIOTHERAPY, area at the PATIENT's surface which is to be
IRRADIATED.
2.120 TYPE TEST: For a particular design of device or EQUIPMENT, a test by the MANUFACTURER
to establish compliance with specified criteria.
2.121 ZERO APPLICATOR: In a system which includes an INTERLOCK against IRRADIATION without
a BEAM APPLICATOR, means to bypass the INTERLOCK.
4 General requirements for tests
This clause of the General Standard applies except as follows:
4.1 Tests
Addition:
aa)
Test procedures described in this standard are generally classified into three grades. Their
requirements are as follows:
Grade A:
In case of TYPE TEST: analysis of EQUIPMENT design, as related to the specified RADIATION
safety provisions, which shall result in a statement included in the ACCOMPANYING DOCUMENTS,
regarding the working principles or constructional means by which the requirement is fulfilled.
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In case of SITE TEST: inspection of the ACCOMPANYING DOCUMENTS for the required information.
Grade B:
Visual inspection or functional test or measurement of the EQUIPMENT. The test shall be in
accordance with the procedure specified in this standard and shall be based on operating
states, including fault condition states, which are achievable without interference with the
EQUIPMENT
circuitry or construction of the .
Grade C:
Functional test or measurement of the EQUIPMENT. The test shall be in accordance with the
principle specified in this standard. The SITE TEST procedure shall be included in the technical
description. When the procedure involves operating states that require interference with the
EQUIPMENT
circuitry or the construction of the , the test should be performed by, or under the
direct supervision of, the MANUFACTURER.
This Particular Standard does not specify procedures or intervals for periodic tests during the
working life of the GAMMA BEAM THERAPY EQUIPMENT.
NOTE – Requirements for tests of RADIATION safety of GAMMA BEAM THERAPY EQUIPMENT are subject to legal
regulations in certain countries.
4.6 Other conditions
Addition:
aa)
SITE TEST information shall be provided in the technical description and shall include:
– statements resulting from grade A TYPE TESTS;
– details of, and results from, grade B and grade C TYPE TESTS;
– specific procedures and test conditions for grade C SITE TESTS;
– instructions on how to generate a described fault condition or, if not practicable, how to
generate a test signal as close as practicable to the source of the signal which would have
generated it, with a statement confirming that the test signal simulates the one which would
be produced in a particular fault condition;
NOTE – In some cases, one test signal may simulate more than one fault condition.
– instructions on how to reset the EQUIPMENT into the NORMAL USE condition after the
completion of the SITE TESTS and how to verify this condition.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
The person responsible for the SITE TESTS shall record the results in a report which will then
form part of the ACCOMPANYING DOCUMENTS. In addition, the SITE TEST report should contain at
least the following:
a) name and address of USER site;
b) MODEL OR TYPE REFERENCE and SERIAL NUMBER of the EQUIPMENT;
c) name, office and address of all personnel taking part in the tests and dates of their
participation;
d) environmental and power supply conditions;
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e) the actual conditions, when test conditions, procedures or devices differ from those given
by the MANUFACTURER, or where the information cannot be derived from this Particular
Standard.
NOTE – SITE TESTS need not be performed by the MANUFACTURER.
4.8 Preconditioning
Addition:
aa)
This test condition applies only to EQUIPMENT parts which have been subjected to the humidity
preconditioning treatment specified in 4.10.
4.10 Humidity preconditioning treatment
Addition:
aa)
The ACCOMPANYING DOCUMENTS shall identify those parts of the EQUIPMENT which:
– are likely to be influenced by the climatic conditions simulated by this treatment;
– have been tested under the conditions set down in this subclause.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
5 Classification
Replacement:
EQUIPMENT shall be marked and/or identified according to its classification as described in
clause 6. This includes:
5.1 According to the type of protection against electric shock:
EQUIPMENT within the scope of this standard shall be CLASS I EQUIPMENT.
5.2 According to the degree of protection against electric shock:
EQUIPMENT within the scope of this standard shall be TYPE B EQUIPMENT.
5.3 According to the degree of protection against harmful ingress of water:
Unless otherwise specified, EQUIPMENT within the scope of this standard shall be ordinary
EQUIPMENT (enclosed EQUIPMENT without protection against ingress of water).
5.4 According to the method(s) of sterilisation or disinfection recommended by the
MANUFACTURER:
Unless otherwise specified, EQUIPMENT (or parts thereof) within the scope of this standard shall
be disinfectable EQUIPMENT (or parts).
5.5 According to the degree of safety of application in the presence of a FLAMMABLE
ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:
EQUIPMENT within the scope of this standard shall be classified as EQUIPMENT not suitable for
use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS
OXIDE.
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5.6 According to the mode of operation:
Unless otherwise specified, EQUIPMENT within the scope of this Standard shall be classified as
suitable for CONTINUOUS OPERATION WITH INTERMITTENT LOADING.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
z) Removable protective means
Addition:
aa)
Where the requirements of this subclause are wholly or partly met by the nature of the
installation, compliance is checked by inspection. The results should be included in the SITE
TEST
report.
6.2 Marking on the inside of the EQUIPMENT or EQUIPMENT parts
Addition:
aa)
Removal of the covers of the RADIATION HEAD shall expose symbol number 14 of table DI of the
General Standard, indicating "Attention, consult ACCOMPANYING DOCUMENTS".
6.3 Marking of controls and instruments
Addition:
aa)
Provision of scales and indications for moving parts:
1) Each available movement shall be provided with a me
...
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