ISO 80601-2-12:2011
(Main)Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: - intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6.
Matériels électriques destinés à être utilisés en présence de poussières combustibles - Partie 2: Méthodes d'essai - Section 1: Méthodes de détermination de la température minimale d'inflammation de la poussière
Indique deux méthodes d'essai pour la détermination de la température minimale d'inflammation de la poussière.
Electrical apparatus for use in the presence of combustible dust - Part 2: Test methods - Section 1: Methods for determining the minimum ignition temperatures of dust
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INTERNATIONAL ISO
STANDARD 80601-2-12
First edition
2011-04-15
Medical electrical equipment —
Part 2-12:
Particular requirements for basic safety
and essential performance of critical care
ventilators
Appareils électromédicaux —
Partie 2-12: Exigences particulières relatives à la sécurité de base et
aux performances essentielles des ventilateurs pulmonaires pour
utilisation en soins intensifs
Reference number
ISO 80601-2-12:2011(E)
©
ISO 2011
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ISO 80601-2-12:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011
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ii © ISO 2011 – All rights reserved
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ISO 80601-2-12:2011(E)
Contents Page
Foreword . vi
Introduction . viii
201.1 Scope, object and related standards . 1
201.1. 1 Scope . 1
201.1. 2 Object . 2
201.1. 3 Collateral standards . 2
201.1. 4 Particular standards . 2
201.2 Normative references . 3
201.3 Terms and definitions . 6
201.4 General requirements . 9
201.4. 3 ESSENTIAL PERFORMANCE . 9
201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE . 9
201.4. 6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 9
201.4. 11.101 * Additional requirements for pressurized gas input . 9
201.4. 11.101.1 Overpressure requirement . 9
201.4. 11.101.2 Compatibility requirement . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.5. 101 * Additional requirements for general requirements for testing of ME EQUIPMENT . 10
201.5. 101.1 VENTILATOR test conditions . 10
201.5. 101.2 * Gas flowrate and leakage specifications . 11
201.5. 101.3 * VENTILATOR testing errors . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.7. 2.3 * Consult ACCOMPANYING DOCUMENTS . 11
201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT
parts . 11
201.7. 2.4.101 Additional requirements for ACCESSORIES . 12
201.7. 2.13.101 Additional requirements for physiological effects . 12
201.7. 2.17.101 Additional requirements for protective packaging . 13
201.7. 4.3 * Unit of measure . 13
201.7. 9.1 Additional general requirements . 13
201.7. 9.2.1.101 Additional general requirements . 14
201.7. 9.2.2.101 * Additional requirements for warnings and safety notices . 14
201.7. 9.2.8.101 * Additional requirements for start-up procedure. 15
201.7. 9.2.9.101 * Additional requirements for operating instructions . 15
201.7. 9.2.12 Cleaning, disinfection, and sterilization . 16
201.7. 9.2.14.101 * Additional requirements for ACCESSORIES, supplementary equipment, used
material . 16
201.7. 9.2.16.101 * Additional requirements for reference to the technical description . 16
201.7. 9.3.1.101 * Additional general requirements . 16
201.7. 9.3.101 Additional requirements for the technical description . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
201.9. 6.2.1.101 Additional requirements for audible acoustic energy . 17
201.9. 101 * Additional requirements for suction procedures . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 20
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ISO 80601-2-12:2011(E)
201.11 Protection against excessive temperatures and other HAZARDS .20
201.11. 6.4 Leakage .20
201.11. 6.5.101 * Additional requirements for ingress of water or particulate matter
into ME EQUIPMENT or ME SYSTEM .21
201.11. 6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM .21
201.11. 6.7 Sterilization of ME EQUIPMENT or ME SYSTEM .21
201.11. 8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS
to ME EQUIPMENT .22
201.11. 8.101.1 TECHNICAL ALARM CONDITION for power supply failure .22
201.11. 8.101.2 INTERNAL ELECTRICAL POWER SOURCE or external reserve electrical power source .22
201.12 Accuracy of controls and instruments and protection against hazardous outputs .23
201.12. 1 * Accurac y of controls and instruments .23
201.12. 1.101 Volume-controlled breath type .23
201.12. 1.102 Pressure-controlled breath type .26
201.12. 1.103 * DELIVERED VOLUME MONITORING .29
201.12. 1.104 * Response of the VENTILATOR to an increase in O concentration .29
2
201.12. 4 Protection against hazardous output .31
201.12. 4.101 Oxygen monitor .31
201.12. 4.102 * Measurement of AIRWAY PRESSURE .31
201.12. 4.103 * Measurement of expired volume and low-volume ALARM CONDITIONS .32
201.12. 4.103.1 VENTILATORS intended to provide a DELIVERED VOLUME > 50 ml .32
201.12. 4.103.2 VENTILATORS intended to provide a DELIVERED VOLUME u 50 ml .32
201.12. 4.104 * MAXIMUM LIMITED PRESSURE PROTECTION DEVICE .33
201.12. 4.105 High-pressure ALARM CONDITION and PROTECTION DEVICE .33
201.12. 4.106 PEEP ALARM CONDITIONS.33
201.12. 4.107 * Obstruction ALARM CONDITION.33
201.12. 4.108 * Partial-occlusion ALARM CONDITION .34
201.12. 101 * Protection against accidental adjustments .34
201.13 HAZARDOUS SITUATIONS and fault conditions .34
201.13. 2.101 * Additional specific SINGLE FAULT CONDITIONS .34
201.13. 102 * Failure of one gas supply to a VENTILATOR .35
201.13. 103 * Independence of ventilation control function and related RISK CONTROL measures .35
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .35
201.14. 101 Software life cycle .35
201.15 Construction of ME EQUIPMENT .35
201.15. 3.5.101 Additional requirements for rough handling .35
201.15. 3.5.101.1 * Shock and vibration .35
201.15. 3.5.101.2 * Shock and vibration for a MOBILE VENTILATOR .36
201.15. 101 Mode of operation .37
201.15. 102 Delivered Oxygen concentration .38
201.15. 103 ACCESSORY self-check .38
201.16 ME SYSTEMS .38
201.16. 1.101 Additional general requirements for ME SYSTEMS .38
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .38
201.17. 101 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS .38
201.101 Gas connections .38
201.101. 1 * Protection against reverse gas leakage .38
201.101. 2 Connection to the MEDICAL GAS PIPELINE SYSTEM .39
201.101. 3 VBS connectors .39
201.101. 3.1 * General .39
201.101. 3.2 Other named ports .39
201.101. 3.2.1 PATIENT-CONNECTION PORT .39
201.101. 3.2.2 GAS OUTPUT PORT and GAS RETURN PORT .39
201.101. 3.2.3 MANUAL ventilation port .39
201.101. 3.2.4 EMERGENCY INTAKE PORT .40
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ISO 80601-2-12:2011(E)
201.101. 3.2.5 FLOW-DIRECTION-sensitive components . 40
201.101. 3.2.6 ACCESSORY port . 40
201.101. 3.2.7 Monitoring probe port . 40
201.101. 3.2.8 Gas EXHAUST PORT . 40
201.102 Requirements for the VBS and ACCESSORIES . 40
201.102. 1 * General . 40
201.102. 2 Labelling . 40
201.102. 3 Breathing tubes . 41
201.102. 4 * Water management . 41
201.102. 4.1 Humidification system . 41
201.102. 4.2 HEAT AND MOISTURE EXCHANGER (HME) . 41
201.102. 5 Gas mixers . 41
201.102. 6 BREATHING SYSTEM FILTERS . 41
201.102. 7 VENTILATOR BREATHING SYSTEMS . 41
201.102. 7.1 Leakage from complete VBS . 41
201.102. 7.2 * Non-invasive ventilation . 42
201.103 * Spontaneous breathing during loss of power supply . 42
201.104 * Training . 43
201.105 * Indication of duration of operation . 43
201.106 SIGNAL INPUT/OUTPUT PART . 43
201.106. 1 General . 43
201.106. 2 * Connection to an electronic health record . 43
201.106. 3 * Connection to a DISTRIBUTED ALARM SYSTEM . 43
201.106. 4 * Connection for remote control . 43
201.107 Display loops . 43
201.107. 1 Pressure-volume loops . 43
201.107. 2 Flow-volume loops . 44
201.108 * Timed ventilatory pause . 44
201.108. 1 Expiratory pause . 44
201.108. 2 Inspiratory pause. 44
202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests . 45
202.6.2.1.10 * Compliance criteria . 45
206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability . 46
208 Medical electrical equipment – Part 1-8: General requirements for basic safety and
essential performance – Collateral Standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical electrical systems . 47
208.6.3.3.2.101 * Additional requirements for characteristics of ALARM CONDITION logging . 47
208.6.8.3.101 Additional requirements for global indefinite ALARM SIGNAL inactivation states . 47
208.6.8.4.101 * Additional requirements for termination of ALARM SIGNAL inactivation . 47
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 48
Annex D (informative) Symbols on marking . 53
Annex AA (informative) Particular guidance and rationale . 55
Annex BB (informative) Reference to the Essential Principles . 72
Bibliography . 74
Alphabetized index of defined terms used in this particular standard . 77
© ISO 2011 – All rights reserved v
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ISO 80601-2-12:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 80601-2-12 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical
equipment in medical practice, Subcommittee SC D, Electrical equipment. The draft was circulated for voting
to the national bodies of both ISO and IEC.
This first edition of ISO 80601-2-12 cancels and replaces the second edition of IEC 60601-2-12:2001. This
edition of ISO 80601-2-12 constitutes a major technical revision of IEC 60601-2-12:2001 and includes an
alignment with the third edition of IEC 60601-1.
The most significant changes are the following modifications:
extending the scope to include the critical care VENTILATOR and its ACCESSORIES, where the characteristics
of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL PERFORMANCE of the VENTILATOR, and
thus not only the critical care VENTILATOR itself;
identification of ESSENTIAL PERFORMANCE for a critical care VENTILATOR and its ACCESSORIES;
modification of the obstruction of the expiratory limb (continuing AIRWAY PRESSURE) ALARM CONDITION
requirement;
and the following additions:
tests for ventilation performance;
tests for mechanical strength;
new symbols;
requirements for a critical care VENTILATOR as a component of an ME SYSTEM;
tests for enclosure integrity (water ingress);
tests for closed suction survivability of the VENTILATOR;
tests for cleaning and disinfection procedures;
PATIENT from the gas pathways.
consideration of contamination of the breathing gas delivered to the
vi © ISO 2011 – All rights reserved
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ISO 80601-2-12:2011(E)
ISO 80601 consists of the following parts, under the general title Medical electrical equipment:
Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic
workstation
Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas
monitors
Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for
body temperature measurement
Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter
equipment for medical use
IEC 80601 consists of the following parts, under the general title Medical electrical equipment:
IEC 80601-2-30: Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers
IEC 80601-2-35: Particular requirements for the basic safety and essential performance of heating
devices using blankets, pads and mattresses and intended for heating in medical use
IEC 80601-2-58: Particular requirements for the basic safety and essential performance of lens removal
devices and vitrectomy devices for ophthalmic surgery
IEC 80601-2-59: Particular requirements for the basic safety and essential performance of screening
thermographs for human febrile temperature screening
IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment
The ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards.
© ISO 2011 – All rights reserved vii
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ISO 80601-2-12:2011(E)
Introduction
In this International 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 IEC 60601-1:2005, CLAUSE 3, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.
In referring to the structure of this standard, the term
“clause” means one of the seventeen 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. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this International Standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular International Standard are by number only.
In this International 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 International Standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this International 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.
The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
and testing organizations may need a transitional period following publication of a new, amended or revised
ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
this International Standard not be adopted for mandatory implementation nationally earlier than 3 years from
the date
...
SLOVENSKI STANDARD
SIST IEC 61241-2-1:1998
01-april-1998
Electrical apparatus for use in the presence of combustible dust - Part 2: Test
methods - Section 1: Methods for determining the minimum ignition temperatures
of dust
Electrical apparatus for use in the presence of combustible dust - Part 2: Test methods -
Section 1: Methods for determining the minimum ignition temperatures of dust
Matériels électriques destinés à être utilisés en présence de poussières combustibles -
Partie 2: Méthodes d'essai - Section 1: Méthodes de détermination de la température
minimale d'inflammation de la poussière
Ta slovenski standard je istoveten z: IEC 61241-2-1
ICS:
29.260.20 (OHNWULþQLDSDUDWL]D Electrical apparatus for
HNVSOR]LYQDR]UDþMD explosive atmospheres
SIST IEC 61241-2-1:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST IEC 61241-2-1:1998
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SIST IEC 61241-2-1:1998
CEI
NORME
IEC
INTERNATIONALE
1241-2-1
INTERNATIONAL
Première édition
STANDARD First edition
1994-12
Matériels électriques destinés à être utilisés
en présence de poussières combustibles -
Partie 2:
Méthodes d'essai —
Section 1: Méthodes de détermination de la
température minimale d'inflammation de la poussière
Electrical apparatus for use in the presence of
combustible dust —
Part 2:
Test methods —
1: Methods for determining the minimum
Section
ignition temperatures of dust
de reproduction réservés — Copyright — all rights reserved
© CEI 1994 Droits
No part of this publication may be reproduced or utilized in
Aucune partie de cette publication ne peut être reproduite ni
any form or by any means, electronic or mechanical,
utilisée sous quelque forme que ce soit et par aucun pro-
including photocopying and microfilm, without permission
cédé, électronique ou mécanique, y compris la photocopie et
in writing from the publisher.
les microfilms, sans l'accord écrit de l'éditeur.
Genève, Suisse
Bureau Central de la Commission Electrotechnique Internationale 3, rue de Varembé
Commission Electrotechnique Internationale CODE PRIX "
International Electrotechnical Commission
PRICE CODE v
MemulyHapopHaa 3nenrporexHwlecnaa HOMHCCHA
IEC
Pour prix, voir catalogue en vigueur
•
For price, see current catalogue
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SIST IEC 61241-2-1:1998
– 3 –
1241-2-1 © IEC:1994
CONTENTS
Page
FOREWORD 5
INTRODUCTION 7
Clause
1 Scope 9
9
2 Normative references
11
3 Definitions
11 4 Method A: Dust layer on a heated surface at a constant temperature
11
4.1 Preparation of dust sample
13
4.2 Test apparatus
15
4.3 Procedure
19
4.4 Test acceptance criteria
21
4.5 Reporting of results
21
4.6 Application of results
23
5 Method B: Dust cloud in a furnace at a constant temperature
23 5.1 Preparation of dust sample
23
5.2 Test apparatus
23
5.3 Procedure
25
5.4 Criterion of ignition
25 5.5 Minimum ignition temperature of a dust cloud
27
5.6 Reporting of results
33
Figures
Annexes
ace and measurement of temperature distribution
Construction of a heated su rf
A
31
on heated su rface
41
Construction of a constant temperature furnace B
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SIST IEC 61241-2-1:1998
1241-2-1 ©IEC:1994 - 5 -
INTERNATIONAL ELECTROTECHNICAL COMMISSION
ELECTRICAL APPARATUS FOR USE IN THE PRESENCE
OF COMBUSTIBLE DUST —
Part 2: Test methods —
Section 1: Methods for determining the minimum
ignition temperatures of dust
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 cooperation 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, prepared by technical committees on
which all the National Committees having a special interest therein are represented, express, as nearly as
possible, an international consensus of opinion on the subjects dealt with.
onal use published in the form of standards, technical
3) They have the form of recommendations for interna ti
reports or guides and they are accepted by the National Committees in that sense.
In order to promote international unification, IEC National Committees undertake to apply IEC International
4)
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.
International Standard IEC 1241-2-1 has been prepared by sub-committee 31H: Apparatus
for use in the presence of ignitable dust, of IEC technical committee 31: Electrical
apparatus for explosive atmospheres.
The text of this standard is based on the following documents:
DIS Report on voting
31H(CO)9 31 H(CO)14
Full information on the voting for the approval of this standard can be found in the report
on voting indicated in the above table.
Annexes A and B form an integral part of this standard.
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SIST IEC 61241-2-1:1998
- 7 -
1241-2-1 © IEC:1994
INTRODUCTION
This section of IEC 1241-2 describes methods for determining the minimum ignition
temperature of dust which are:
- method A: Dust layer on a heated surface at a constant temperature (clause 4);
- method B: Dust cloud in a furnace at a constant temperature (clause 5).
Method A determines the minimum ignition temperature of a dust layer on a prescribed
heated surface.
Method B determines the minimum ignition temperature of a dust cloud within a prescribed
heated furnace.
The test methods are of a general nature, and may be used for purposes of comparison,
but in certain industrial situations further tests may be necessary.
The methods for determining the minimum ignition temperatures are not suitable for use
with recognized explosives, for example, gunpowder, dynamite, or mixtures of substances
which may, under some circumstances, behave similarly.
Where there is doubt, an indication of the existence of a hazard due to explosive pro-
perties may be obtained by testing a very small quantity of the dust on a surface at 400 °C
or higher, located remotely from the operator.
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SIST IEC 61241-2-1:1998
1241-2-1 ©IEC:1994 - 9 -
ELECTRICAL APPARATUS FOR USE IN THE PRESENCE
OF COMBUSTIBLE DUST —
Part 2: Test methods —
Section 1: Methods for determining the minimum
ignition temperatures of dust
1 Scope
This section of IEC 1241-2 specifies two test methods for determining the minimum
ignition temperatures of dust.
The methods are not suitable for use with substances having explosive properties.
Method A (clause 4) is applicable to the determination of the minimum temperature of a
ace which will result in the decomposition and/or ignition of a layer of
prescribed hot su rf
dust of a specified thickness deposited on it. The method is particularly relevant to
industrial equipment with which dust is present on hot su rfaces in thin layers exposed to
the atmosphere.
Method B (clause 5) is applicable to the determination of the minimum temperature of a
ace which will result in the ignition of a cloud of a given sample of dust
prescribed hot su rf
or other particulate solid. The test is intended to be carried out as a complementary test
after determining the minimum ignition temperature of a dust layer by method A of this
standard.
NOTES concerning method B
1 Because the method of operation of the furnace gives short residence times for dust particles within it,
this method of test is applicable to industrial equipment where dust is present as a cloud for a short time.
This method of test is of small scale and the results are not necessarily representative of all industrial
conditions.
2 The method is not applicable to dusts which may, over a longer period of time than provided for in the
test method, produce from deposits gases generated during pyrolysis or smouldering.
2 Normative references
The following normative documents contain provisions which, through reference in this
text, constitute provisions of this section of IEC 1241-2. At the time of publication, the
editions indicated were valid. All normative documents are subject to revision, and parties
to agreements based on this section of IEC 1241-2 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated
below. Members of IEC and ISO maintain registers of currently valid International
Standards.
ISO 565: 1990, Test sieves - Metal wire cloth, perforated metal plate and electroformed
sheet - Nominal sizes of opening
ISO 4225: 1980: Air quality - General aspects - Vocabulary
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SIST IEC 61241-2-1:1998
- 11 -
1241-2-1 © IEC:1994
3 Definitions
For the purpose of this section of IEC 1241-2, the following definitions apply:
Small solid particles in the atmosphere which settle out under their own
3.1 dust:
weight, but which may remain suspended in air for some time (includes dust and grit as
defined in ISO 4225).
Ignition is considered to have occurred if glowing or
3.2 ignition of a dust layer:
flaming is initiated in the material, or a temperature of 450 °C or more, or a temperature
ace, is measured in
rise of 250 K or more above the temperature of the prescribed hot su rf
the test.
3.3 minimum ignition temperature of a dust layer: Lowest temperature of a hot
ace at which ignition occurs in a dust layer of specified thickness on this hot su rface.
su rf
NOTES
1 Because of the wide range of processes in industry, the ignition of dust layers may be dependent upon
local conditions. This method of test is not necessarily representative of all industrial conditions, where
account may need to be taken of such factors as the presence of thick layers of dust and of the distribution
of temperature in the environment.
2 When carrying out this test, it is essential that all necessary precautions be taken to safeguard the
health of personnel, for example, against the risk of fire, explosion, inhalation of smoke and any toxic
products of combustion.
Initiation of an explosion by the transfer of energy to a
3.4 ignition of a dust cloud:
dust cloud in air.
3.5 ignition temperature of a dust cloud: Lowest temperature of the hot inner wall of
a furnace at which ignition occurs in a dust cloud in air contained therein.
NOTE - When carrying out this test, it is essential that all necessary precautions be taken to safeguard
the health of personnel, for example, against the risk of fire, explosion, inhalation of smoke and any toxic
products of combustion.
4 Method A: Dust layer on a heated surface at a constant temperature
4.1 Preparation of dust sample
The sample shall be prepared so as to be homogeneous and representative of the dust
received for consideration.
The dust sample to be tested shall, in general, be able to pass through a woven metal wire
cloth or a square hole perforated plate test sieve with a nominal size of aperture of 200 gm
(for supplementary sizes, see ISO 565). If it is necessary to test a coarser dust, passing a
ure up to 500 gm, the fact shall be stated in the test
test sieve with a nominal size of ape rt
repo rt .
---------------------- Page: 8 ----------------------
SIST IEC 61241-2-1:1998
1241-2-1 ©IEC:1994 - 13 -
Any apparent changes noted in the properties of the dust during preparation of the
sample, for example, by sieving or owing to temperature or humidity conditions, shall be
stated in the test report.
4.2
Test apparatus
The apparatus is shown schematically in figure A.1. Essential details and pe rformance
requirements are given in the following subclauses. Methods of construction to enable
these requirements to be met are described in annex A.
4.2.1 Heated surface
The heated su rface shall consist of a circular metal plate and shall provide a working area
of at least 200 mm in diameter and be not less than 20 mm in thickness. The plate shall be
heated electrically and its temperature shall be controlled by a device for which the
sensing element is a thermocouple mounted in the plate near the centre and with its
junction within 1 mm ± 0,5 mm of the upper su rface and in good thermal contact with the
plate.
A similar thermocouple shall be mounted near the control thermocouple in a similar
manner, and shall be connected to a temperature recorder to record the temperature of
the su rface during a test. The heated surface and its control device shall satisfy the
following pe
rformance requirements:
a) the heated su rface shall be capable of attaining a maximum temperature of 400 °C
without a dust layer in position;
±5
K throughout
b) the temperature of the heated su rface shall be constant to within
the period of a test;
c) when the heated su rface has reached a steady state, the temperature across the
surface shall be uniform to within ±5 K when measured across two diameters at right
angles, by the procedure described in annex B. This requirement shall be satisfied at
nominal su ace temperatures of 200 °C and 350 °C;
rf
d) the temperature control shall be such that the recorded surface temperature does
not change by more than ±5 K during the placing of the dust layer, and it shall be
restored to within ±2 K of the previous value within 5 min of placing the dust layer;
e) temperature control and measurement devices shall be calibrated and shall have
±3
limits of inaccuracy of K.
4.2.2
Dust layer thermocouple
A fine thermocouple (0,20 mm to 0,25 mm diameter) of chromel-alumel or other suitable
material shall be stretched across the heated su rface, and parallel to it, at a height of
between 2 mm and 3 mm from it with the junction over the centre of the plate. This thermo-
couple shall be connected to a temperature recorder in order to determine the behaviour
of the dust layer during the test.
4.2.3 Temperature measurements
Temperature measurements using thermocouples shall be made either relative to a fixed
reference junction or with automatic cold junction compensation. In either case, calibration
shall satisfy the requirements of 4.2.1 e).
---------------------- Page: 9 ----------------------
SIST IEC 61241-2-1:1998
1241-2-1 © IEC:1994 - 15 -
4.2.4 Ambient temperature measurements
The ambient temperature shall be measured by a thermometer placed not more than 1 m
ace, but shielded from heat convection and radiation from the surface.
from the heated su rf
The ambient temperature shall be within the range 15 °C to 35 °C.
4.2.5 Dust layers
Dust layers shall be prepared by filling the cavity formed by placing a metal ring of appro-
priate height on the heated su rface and levelling the layer to the top of the ring. The ring
shall have an internal diameter of nominally 100 mm and shall have slots at opposite ends
of a diameter to clear the test thermocouple (figure A.2). The ring shall be left in place
during a test.
A given dust shall be tested in a layer of 5,0 mm ± 0,1 mm depth. For predictive purposes
(see 4.6) a second depth (such as 12,5 mm ± 0,1 mm or 15,0 mm ± 1 mm) is useful.
Rings of appropriate depths will be required.
4.2.6
Formation of dust layer
The dust layer shall be formed without compressing it unduly. That is to say, the dust shall
be put into the ring with a spatula and distributed mainly with sideways movement of the
spatula until the ring is slightly overfilled. The layer shall then be levelled by drawing a
straight edge across the top of the ring. Any excess should be swept away.
For each type of dust, a layer shall be formed in the above manner on a sheet of paper
whose weight is known and weighed. The density shall be calculated from the mass of the
dust and the filled volume of the ring, and shall be reported.
4.3 Procedure
4.3.1
General
Ignition in particulate or porous solids exposed to elevated temperatures is generally
preceded by a more or less protracted period of self-heating (usually due to atmospheric
oxidation). Depending on the temperature of exposure, self-heating may result in no more
than a transient, though sometimes substantial, rise in temperature within the solid which
does not lead to propagation of combustion. Further, the "induction period" for ignition, at
temperatures near to the minimum required for ignition is usually many times greater than
for ignition in dust clouds or in gases and vapours (minutes or hours rather than seconds).
For both reasons the recognition of the minimum ignition temperature of dust layers is less
straightforward than for dust clouds or for gases and vapours. It is necessary especially to
be ce ain that failure to ignite at a given temperature is not merely because a test was
rt
terminated prematurely.
---------------------- Page: 10 ----------------------
SIST IEC 61241-2-1:1998
-17 -
1241-2-1 © IEC:1994
The occurrence of ignition in a layer of dust on a surface at a given temperature depends
critically on the balance between the rate of heat generation ("self-heating") in the layer
and the rate of heat loss to the surroundings. The temperature at which ignition of a given
material occurs depends, therefore, on the thickness of the layer. Values determined for
two or more thicknesses of a given dust may be used for predictive purposes (see 4.6).
Following the recommended procedure, ignition shall be considered to have occurred if:
a) visible glowing or flaming is observed (figure 3a), or
a temperature of 450 °C, is measured or
b)
a temperature rise of 250 K above the temperature of the heated plate (figure 3c), is
c)
measured.
With regard to items b and c above, ignition shall not be considered to have occurred if it
can be shown that the reaction does not propagate to glowing or flaming. The temperature
shall be measured by thermocouple (see 4.2.2) It will usually be found that, provided the
temperature of the heated surface is high enough, the temperature in the layer will slowly
increase to a maximum value which may be in excess of the temperature of the heated
surface and then slowly fall to a steady value below the temperature of the heated surface
(figure 3b). This behaviour is evidence of self-heating in the dust layer and it may often be
accompanied by a discoloration of the dust but without active and visible combustion of
the layer. If the temperature of the heated surface is slightly higher, the temperature
measured in the dust layer will continue to rise instead of passing through a maximum.
Some materials exhibit more than one stage of self-heating, and it may sometimes be
necessary to prolong the test in order to fully explore this possibility. With organic dust,
combustion will usually take the form of charring followed by the appearance of
smouldering with glowing which will progress through the layer and leave a residue of ash.
With dust layers composed of certain divided metals, ignition may be characterized by the
relatively sudden appearance of highly incandescent smouldering combustion progressing
rapidly through the layer.
In the determination of the minimum ignition temperature for a layer of given thickness,
repeated trials are carried out, using a fresh layer of dust each time and with up-and-down
adjustments to the temperature of the heated surface until a temperature is found which is
high enough to cause ignition in the layer but which is no more than 10 K higher than a
temperature which fails to cause ignition. The highest temperature at which ignition fails to
occur shall be confirmed by continuing the test long enough to establish that any self-
heating is decreasing in rate; that is, the temperature at the point of measurement in the
layer is decreasing to a steady value lower than the temperature of the heated surface.
4.3.2 Method
The apparatus shall be set up in a position free from draughts, and preferably under a
hood capable of extracting smoke and fumes.
---------------------- Page: 11 ----------------------
SIST IEC 61241-2-1:1998
1241-2-1 © IEC:1994 -
19 -
The temperature of the heated surface shall be adjusted to the desired value and shall be
allowed to become steady within the prescribed limits of 4.2.1 b). A metal ring of the
required height shall be placed centrally on the heated surface and this ring shall be filled
with the dust to be tested and levelled off within a period of 2 min. The recorder for the
dust layer thermocouple shall then be started.
The test shall be continued until it is ascertained either that the layer has ignited, either
visually or by the thermocouple recording, or has self-heated without igniting and is sub-
sequently cooling down.
If, after a period of 30 min, no self-heating is apparent the test should be terminated and
repeated at a higher temperature. If ignition or self-heating occurs the test shall be
repeated at a lower temperature, if necessary, prolonging the test beyond 30 min. Test
...
NORME ISO
INTERNATIONALE 80601-2-12
Première édition
2011-04-15
Appareils électromédicaux —
Partie 2-12:
Exigences particulières relatives à la
sécurité de base et aux performances
essentielles des ventilateurs pulmonaires
pour utilisation en soins intensifs
Medical electrical equipment —
Part 2-12: Particular requirements for basic safety and essential
performance of critical care ventilators
Numéro de référence
ISO 80601-2-12:2011(F)
©
ISO 2011
---------------------- Page: 1 ----------------------
ISO 80601-2-12:2011(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2011
Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publication ne peut être reproduite ni utilisée sous
quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit
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Publié en Suisse
ii © ISO 2011 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 80601-2-12:2011(F)
Sommaire Page
Avant-propos . vii
Introduction . ix
201.1 Domaine d'application, objet et normes collatérales . 1
201.1. 1 Domaine d'application . 1
201.1. 2 Objet . 2
201.1. 3 Normes collatérales . 2
201.1. 4 Normes particulières . 2
201.2 Références normatives . 3
201.3 Termes et définitions . 6
201.4 Exigences générales . 9
201.4. 3 PERFORMANCES ESSENTIELLES. 9
201.4. 3.101 * Exigences supplémentaires relatives aux PERFORMANCES ESSENTIELLES . 9
201.4. 6 * Parties d'APPAREIL EM ou de SYSTÈME EM en contact avec le PATIENT . 10
201.4. 11.101 * Exigences supplémentaires relatives aux entrées de gaz sous pression . 10
201.4. 11.101.1 Exigences relatives à la surpression . 10
201.4. 11.101.2 Exigences de compatibilité . 10
201.5 Exigences générales d'essai d'un APPAREIL EM . 11
201.5. 101 * Exigences supplémentaires pour les exigences générales d'essai d'un
APPAREIL EM . 11
201.5. 101.1 Conditions d'essai du VENTILATEUR . 11
201.5. 101.2 * Spécifications des débits de gaz et des fuites . 11
201.5. 101.3 * Erreurs d'essai du VENTILATEUR . 11
201.6 Classification des APPAREILS EM et des SYSTÈMES EM . 11
201.7 Identification, marquage et documentation des APPAREILS EM . 11
201.7. 2.3 * Consultation de DOCUMENTS D'ACCOMPAGNEMENT . 12
201.7. 2.101 Exigences supplémentaires de marquage sur l'extérieur des APPAREILS EM ou
parties des APPAREILS EM . 12
201.7. 2.4.101 Exigences supplémentaires pour les ACCESSOIRES . 13
201.7. 2.13.101 Exigences supplémentaires en matière d'effets physiologiques . 13
201.7. 2.17.101 Exigences supplémentaires en matière d'emballage de protection . 13
201.7. 4.3 * Unité de mesure . 14
201.7. 9.1 Exigences générales supplémentaires . 14
201.7. 9.2.1.101 Exigences générales supplémentaires . 14
201.7. 9.2.2.101 * Exigences supplémentaires en matière d'avertissements et de consignes de
sécurité 14
201.7. 9.2.8.101 * Exigences supplémentaires en matière de procédure de démarrage . 15
201.7. 9.2.9.101 * Exigences supplémentaires en matière d'instructions de fonctionnement . 15
201.7. 9.2.12 Nettoyage, désinfection et stérilisation . 16
201.7. 9.2.14.101 * Exigences supplémentaires en matière d'ACCESSOIRES, d'équipements
supplémentaires et de fournitures utilisées . 16
201.7. 9.2.16.101 * Exigences supplémentaires en matière de référence à la description
technique 17
201.7. 9.3.1.101 * Exigences générales supplémentaires . 17
201.7. 9.3.101 Exigences supplémentaires en matière de description technique . 17
201.8 Protection contre les DANGERS d'origine électrique provenant des APPAREILS EM . 17
201.9 Protection contre les DANGERS mécaniques des APPAREILS EM et SYSTÈMES EM . 17
201.9. 6.2.1.101 Exigences supplémentaires en matière d'énergie acoustique . 18
© ISO 2011 – Tous droits réservés iii
---------------------- Page: 3 ----------------------
ISO 80601-2-12:2011(F)
201.9. 101 * Exigences supplémentaires en matière de procédures d'aspiration .19
201.10 Protection contre les DANGERS dus aux rayonnements involontaires ou excessifs .21
201.11 Protection contre les températures excessives et les autres DANGERS .21
201.11. 6.4 Fuite .21
201.11. 6.5.101 * Exigences supplémentaires en matière de pénétration d'eau ou de corps
solides dans l'APPAREIL EM ou le SYSTÈME EM .21
201.11. 6.6 * Nettoyage et désinfection des APPAREILS EM et des SYSTÈMES EM .22
201.11. 6.7 Stérilisation des APPAREILS EM ou des SYSTÈMES EM .22
201.11. 8.101 Exigences supplémentaires en matière de coupure de l'alimentation/du RÉSEAU
D'ALIMENTATION électrique vers l'APPAREIL EM .22
201.11. 8.101.1 CONDITION D'ALARME TECHNIQUE de panne d'alimentation électrique .22
201.11. 8.101.2 SOURCE ÉLECTRIQUE INTERNE ou source électrique en réserve externe .23
201.12 Précision des commandes, des instruments et de la protection contre les caractéristiques
de sortie présentant des risques .23
201.12. 1 * Précision des commandes et des instruments .23
201.12. 1.101 Ventilation en mode volume contrôlé .24
201.12. 1.102 Ventilation en mode pression contrôlée .27
201.12. 1.103 * SURVEILLANCE DU VOLUME DÉLIVRÉ .30
201.12. 1.104 * Réponse du VENTILATEUR à une augmentation de la teneur en O .30
2
201.12. 4 Protection contre les caractéristiques de sortie présentant des risques .32
201.12. 4.101 Moniteur d'oxygène .32
201.12. 4.102 * Mesure de la PRESSION DES VOIES AÉRIENNES .32
201.12. 4.103 * Mesure du volume expiré et CONDITIONS D'ALARME de faible volume .33
201.12. 4.103.1 VENTILATEURS destiné à fournir un VOLUME DÉLIVRÉ > 50 ml .33
201.12. 4.103.2 VENTILATEURS destinés à fournir un VOLUME DÉLIVRÉ ≤ 50 ml .33
201.12. 4.104 * DISPOSITIF DE PROTECTION DE LA PRESSION LIMITÉE MAXIMALE .34
201.12. 4.105 CONDITION D'ALARME de pression élevée et DISPOSITIF DE PROTECTION.34
201.12. 4.106 CONDITIONS D'ALARME DE PEEP .34
201.12. 4.107 * CONDITION D'ALARME d'obstruction .34
201.12. 4.108 * CONDITION D'ALARME d'occlusion partielle .35
201.12. 101 * Protection contre la modification accidentelle de commandes .35
201.13 SITUATIONS DANGEREUSES et conditions de défaut .35
201.13. 2.101 * CONDITIONS DE PREMIER DÉFAUT particulières supplémentaires .35
201.13. 102 * Défaillance d'une alimentation en gaz d'un VENTILATEUR .36
201.13. 103 * Indépendance de la fonction de commande de la ventilation et des mesures de
CONTRÔLE DU RISQUE associées .36
201.14 SYSTÈMES ÉLECTROMÉDICAUX PROGRAMMABLES (SEMP) .36
201.14. 101 Cycle de vie logiciel .36
201.15 Construction de l'APPAREIL EM .36
201.15. 3.5.101 Exigences supplémentaires en matière de manipulation brutale .36
201.15. 3.5.101.1 * Choc et vibrations .36
201.15. 3.5.101.2 * Choc et vibrations d'un VENTILATEUR MOBILE .37
201.15. 101 Mode de fonctionnement .38
201.15. 102 Teneur en oxygène délivré .39
201.15. 103 Contrôle automatique des ACCESSOIRES .39
201.16 SYSTÈMES EM .39
201.16. 1.101 Exigences générales supplémentaires en matière de SYSTÈMES EM.39
201.17 Compatibilité électromagnétique des APPAREILS EM et des SYSTÈMES EM .39
201.17. 101 Exigences supplémentaires en matière de compatibilité électromagnétique des
APPAREILS EM et des SYSTÈMES EM .39
201.101 Raccordements de gaz .39
201.101. 1 * Protection contre les rétropollutions .39
201.101. 2 Raccordement au système de distribution de gaz médicaux .40
201.101. 3 Raccords du VBS .40
201.101. 3.1 * Généralités .40
iv © ISO 2011 – Tous droits réservés
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ISO 80601-2-12:2011(F)
201.101. 3.2 Autres orifices désignés . 40
201.101. 3.2.1 Orifice de raccordement côté patient . 40
201.101. 3.2.2 Orifice de sortie du gaz et orifice de retour du gaz . 40
201.101. 3.2.3 Orifice de ventilation MANUELLE . 40
201.101. 3.2.4 Orifice d'aspiration de secours . 41
201.101. 3.2.5 Dispositifs conditionnant le sens du débit . 41
201.101. 3.2.6 Orifice d'accessoire . 41
201.101. 3.2.7 Orifice de la sonde de surveillance . 41
201.101. 3.2.8 Orifice d'évacuation du gaz . 41
201.102 Exigences relatives au VBS et à ses ACCESSOIRES . 41
201.102. 1 * Généralités . 41
201.102. 2 Étiquetage . 42
201.102. 3 Tubes respiratoires . 42
201.102. 4 * Gestion de l'eau . 42
201.102. 4.1 Système d'humidification . 42
201.102. 4.2 Échangeur de chaleur et d'humidité (ech) . 42
201.102. 5 Mélangeurs de gaz . 42
201.102. 6 Filtres de système respiratoire . 42
201.102. 7 Systèmes respiratoire du ventilateur . 42
201.102. 7.1 Fuite d'un VBS complet . 42
201.102. 7.2 * Ventilation non invasive . 43
201.103 * Respiration spontanée pendant la perte d'alimentation . 43
201.104 * Formation . 44
201.105 * Indication de la durée de fonctionnement . 44
201.106 ENTRÉE/SORTIE DE SIGNAL . 44
201.106. 1 Généralités . 44
201.106. 2 * Connexion à un dossier médical informatisé . 44
201.106. 3 * Connexion à un système d'alarme distribué . 44
201.106. 4 * Connexion à une commande à distance . 44
201.107 Affichage de courbes boucle . 45
201.107. 1 Boucles pression-volume . 45
201.107. 2 Boucles débit- volume . 45
201.108 * Pause ventilatoire temporisée . 45
201.108. 1 Pause expiratoire . 45
201.108. 2 Pause inspiratoire . 46
202 Appareils électromédicaux – Partie 1-2: Exigences générales pour la sécurité de base et
les performances essentielles – Norme collatérale: Compatibilité électromagnétique –
Exigences et essais . 46
202.6.2.1.10 * Critères de conformité . 46
206 Appareils électromédicaux – Partie 1-6: Exigences générales pour la sécurité de base et
les performances essentielles – Norme collatérale: Aptitude à l'utilisation . 47
208 Appareils électromédicaux – Partie 1-8: Exigences générales pour la sécurité de base et
les performances essentielles – Norme collatérale: Exigences générales, essais et guide
pour les systèmes d'alarme des appareils et des systèmes électromédicaux . 48
208.6.3.3.2.101 * Exigences supplémentaires en matière de caractéristiques de journalisation
de CONDITION D'ALARME . 48
208.6.8.3.101 Exigences supplémentaires en matière de désactivation globale indéfinie du
SIGNAL D'ALARME . 48
208.6.8.4.101 * Exigences supplémentaires en matière d'annulation de la désactivation des
SIGNAUX D'ALARME . 49
© ISO 2011 – Tous droits réservés v
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ISO 80601-2-12:2011(F)
Annexe C (informative) Guide des exigences en matière de marquage et d'étiquetage des
APPAREILS et SYSTÈMES EM .50
Annexe D (informative) Symboles des marquages .55
Annexe AA (informative) Lignes directrices particulières et justifications .57
Annexe BB (informative) Référence aux principes essentiels .76
Bibliographie .78
Index alphabétique des termes définis utilisés dans la présente norme particulière .81
vi © ISO 2011 – Tous droits réservés
---------------------- Page: 6 ----------------------
ISO 80601-2-12:2011(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée
aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO 80601-2-12 a été élaborée par un groupe de travail mixte du comité technique ISO/TC 121, Matériel
d'anesthésie et de réanimation respiratoire, sous-comité SC 3, Ventilateurs pulmonaires et équipements
connexes et le Comité technique CEI/TC 62, Équipements électriques dans la pratique médicale, sous-comité
SC D, Appareils électromédicaux. Le projet a été circulé pour le vote aux membres nationaux de l'ISO et de la
CEI.
Cette première édition de l'ISO 80601-2-12 annule et remplace la deuxième édition de
la CEI 60601-2-12:2001. La présente édition de l'ISO 80601-2-12 constitue une révision technique majeure de
la CEI 60601-2-12:2001 et s'aligne sur la troisième édition de la CEI 60601-1.
Les modifications les plus significatives sont les suivantes:
extension du domaine d'application pour inclure non seulement le VENTILATEUR en lui-même, mais
également ses ACCESSOIRES, lorsque les caractéristiques de ces ACCESSOIRES peuvent affecter la
SÉCURITÉ DE BASE et les PERFORMANCES ESSENTIELLES du VENTILATEUR;
identification des PERFORMANCES ESSENTIELLES d'un VENTILATEUR pour utilisation en soins intensifs et ses
ACCESSOIRES;
modification de l'exigence relative à la condition d'alarme d'obstruction de branche expiratoire (PRESSION
RESPIRATOIRE continue);
et les ajouts suivants:
essais des performances de ventilation;
essais de résistance mécanique;
nouveaux symboles;
exigences relatives au VENTILATEUR pour utilisation en soins intensifs en tant que composant d'un
SYSTÈME EM;
© ISO 2011 – Tous droits réservés vii
---------------------- Page: 7 ----------------------
ISO 80601-2-12:2011(F)
essais d'intégrité de l'enveloppe (pénétration d'eau);
essais de la capacité du VENTILATEUR à résister sans dommage à une procédure d'aspiration en circuit
fermé du VENTILATEUR;
essais des modes opératoires de nettoyage et de désinfection; et
considérations de contamination du gaz respiratoire délivré au PATIENT par les chemins du gaz.
L'ISO 8060 1 comprend les parties suivantes, présentées sous le titre général Appareils électromédicaux:
Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des
ventilateurs pulmonaires pour utilisation en soins intensifs
Partie 2-13: Exigences particulières de sécurité de base et de performance essentielle pour les systèmes
d'anesthésie
Partie 2-55: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles
des moniteurs de gaz respiratoire
Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles
des thermomètres médicaux pour mesurer la température de corps
Partie 2-61: Exigences particulières pour la sécurité de base et les performances essentielles pour les
oxymètres de pouls
La CEI 80601 comprend les parties suivantes, présentées sous le titre général Appareils électromédicaux:
CEI 80601-2-30: Exigences particulières de sécurité de base et de performances essentielles des
sphygmomanomètres non invasifs automatiques;
CEI 80601-2-35: Exigences particulières pour la sécurité de base et les performances essentielles des
dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destinés
au réchauffage des patients en usage médical;
CEI 80601-2-58: Exigences particulières pour la sécurité de base et les performances essentielles des
dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique;
CEI 80601-2-59: Exigences particulières relatives à la sécurité fondamentale et aux perfomances
essentielles des imageurs thermiques pour le dépistage des humains fébriles;
CEI 80601-2-60: Exigences particulières pour la sécurité de base et les performances essentielles des
équipements dentaires.
La famille de normes de l'ISO et de la CEI 80601 font également partie de la famille de normes de la
CEI 60601.
viii © ISO 2011 – Tous droits réservés
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ISO 80601-2-12:2011(F)
Introduction
Dans la présente Norme internationale, les caractères suivants sont utilisés:
exigences et définitions: caractères romains;
modalités d'essai: caractères italiques.
Les indications de nature informative apparaissant hors des tableaux, comme les notes, les exemples et
les références: petits caractères. Le texte normatif à l'intérieur des tableaux est également en petits
caractères.
TERMES DÉFINIS DANS LA CEI 60601-1:2005, ARTICLE 3, DANS LA PRÉSENTE NORME OU EN NOTE: PETITES
LETTRES CAPITALES.
Concernant la structure de la présente norme, le terme
«article» désigne l'une des dix-sept sections numérotées dans la table des matières, avec toutes ses
subdivisions (par exemple l'Article 7 inclut les paragraphes 7.1, 7.2, etc.);
«paragraphe» désigne une subdivision numérotée d'un article (par exemple 201.7.1, 201.7.2 et 201.7.2.1
sont tous des paragraphes de l'Article 201.7).
Dans la présente Norme internationale, les références à des articles sont précédées du mot «Article» suivi du
numéro de l'article concerné. Dans la présente Norme internationale, les références aux paragraphes utilisent
uniquement le numéro du paragraphe concerné.
Dans la présente Norme internationale, la conjonction «ou» est utilisée avec la valeur d'un «ou inclusif», ainsi
un énoncé est vrai si une combinaison des conditions, quelle qu'elle soit, est vraie.
Les formes verbales utilisées dans la présente Norme internationale sont conformes à l'usage donné à
l'Annexe H des Directives ISO/CEI, Partie 2. Pour les besoins de la Norme internationale:
«devoir» signifie que la conformité à une exigence ou à un essai est obligatoire pour la conformité à la
présente norme;
«il convient/il est recommandé» signifie que la conformité à une exigence ou à un essai est
recommandée mais n'est pas obligatoire pour la conformité à la présente norme;
«pouvoir» est utili
...
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