SIST EN 60601-2-12:2006

SLOVENSKI SIST EN 60601-2-12:2006

STANDARD
oktober 2006
Medicinska električna oprema – 2-12. del: Posebne varnostne zahteve za
pljučne ventilatorje – Ventilatorji za kritično oskrbo (IEC 60601-2-12:2001)
Medical electrical equipment – Part 2-12: Particular requirements for the safety of
lung ventilators - Critical care ventilators (IEC 60601-2-12:2001)
ICS 11.040.10 Referenčna številka
SIST EN 60601-2-12:2006(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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EUROPEAN STANDARD
EN 60601-2-12

NORME EUROPÉENNE
June 2006
EUROPÄISCHE NORM

ICS 11.040.10


English version


Medical electrical equipment
Part 2-12: Particular requirements
for the safety of lung ventilators –
Critical care ventilators
(IEC 60601-2-12:2001)


Appareils électromédicaux  Medizinische elektrische Geräte
Partie 2-12: Règles particulières de Teil 2-12: Besondere Festlegungen
sécurité pour ventilateurs pulmonaires – für die Sicherheit von Beatmungsgeräten
Ventilateurs pour utilisation en soins für den medizinischen Gebrauch –
intensifs Beatmungsgeräte für die Intensivpflege
(CEI 60601-2-12:2001) (IEC 60601-2-12:2001)




This European Standard was approved by CENELEC on 2006-05-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-12:2006 E

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EN 60601-2-12:2006 - 2 -
Foreword
The text of the International Standard IEC 60601-2-12:2001, prepared by SC 62D, Electromedical
equipment, of IEC TC 62, Electrical equipment in medical practice, and ISO TC 121/SC 3, Lung
ventilators and related equipment, was submitted to the Unique Acceptance Procedure and was
approved by CENELEC as EN 60601-2-12 on 2006-05-01.
The following dates were fixed:
- latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2007-05-01
- latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2009-05-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard replaces EN 794-1:1997, Lung ventilators - Part 1: Particular requirements for
critical care ventilators, which was prepared by CEN/TC 215 and will be withdrawn by CEN.
Other European Standards which may be of interest relating to lung ventilators prepared by CEN/TC 215
are:
– EN 794-3:1998, Lung ventilators – Part 3: Particular requirements for emergency and transport
ventilators
– EN ISO 10651-2:2004, Lung ventilators for medical use - Particular requirements for basic safety and
essential performance – Part 2: Home care ventilators for ventilator-dependent patients
– EN ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered
resuscitators
– EN ISO 10651-6:2004, Lung ventilators for medical use - Particular requirements for basic safety and
essential performance - Part 6: Home-care ventilatory support devices.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS PARTICULAR STANDARD: SMALL
CAPITALS.
Annexes ZA, ZB and ZZ have been added by CENELEC.
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- 3 - EN 60601-2-12:2006
Endorsement notice
The text of the International Standard IEC 60601-2-12:2001 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-13 NOTE  IEC 60601-2-13:2003 is harmonized as EN 60601-2-13:2006 (not modified).
ISO 594-1 NOTE  Harmonized as EN ISO 20594-1:1993 (not modified).
ISO 10651-2 NOTE  Harmonized as EN ISO 10651-2:2004 (not modified).

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EN 60601-2-12:2006 - 4 -
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:1990/A2:1995:


IEC 60079-4 1975 Electrical apparatus for explosive gas - -
+ A1 1995 atmospheres
 Part 4: Method of test for ignition temperature
+ IEC 60079-4A 1970 First Supplement


IEC 60601-1 1988 Medical electrical equipment EN 60601-1 1990
 Part 1: General requirements for safety + corr. July 1994
+ A1 1991 + A1 1993
 + corr. July 1994
+ A2 1995
+ corr. June 1995 + A2 1995
 + A13 1996


Replacement in Annex ZA of EN 60601-1:1990/A2:1995:


1)
IEC 60417-1 2000 Graphical symbols for use on equipment -
-
Part 1: Overview and application


1)
IEC 60417-2 1998 Graphical symbols for use on equipment - -
+ A1 2000 Part 2: Symbol originals


IEC 60601-1-1 2000 Medical electrical equipment EN 60601-1-1 2001
Part 1-1: General requirements for safety -
Collateral standard: Safety requirements for
medical electrical systems


IEC 60601-1-2 2001 Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests


IEC 60601-1-4 1996 Medical electrical equipment EN 60601-1-4 1996
+ A1 1999 Part 1-4: General requirements for safety - + A1 1999
Collateral standard: Programmable electrical
medical systems



1)
IEC 60417-1 and 60417-2 were superseded by the IEC 60417 database.

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- 5 - EN 60601-2-12:2006
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:1990/A2:1995:


2)
ISO 4135 1995 Anaesthesiology - Vocabulary - -


ISO 5356-1 1996 Anaesthetic and respiratory equipment - - -
Conical connectors
Part 1: Cones and sockets


ISO 5356-2 1987 Anaesthetic and respiratory equipment - - -
Conical connectors
Part 2: Screw-threaded weight-bearing
connectors


ISO 5359 2000 Low-pressure hose assemblies for use with - -
medical gas systems


ISO 5362 2000 Anaesthetic reservoir bags - -


ISO 5367 2000 Breathing tubes intended for use with - -
anaesthetic apparatus and ventilators


ISO 7000 1989 Graphical symbols for use on equipment - - -
Index and synopsis


3)
ISO 7396 1987 Non-flammable medical gas pipeline systems - -


4)
ISO 7767 1997 Oxygen monitors for monitoring patient - -
breathing mixtures - Safety requirements


ISO 8835-3 1997 Inhalational anaesthesia systems - -
Part 3: Anaesthetic gas scavenging systems
- Transfer and receiving systems


ISO 9360-1 2000 Anaesthetic and respiratory equipment - - -
Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans
Part 1: HMEs for use with minimum tidal
volumes of 250 ml


ISO 9360-2 2001 Anaesthetic and respiratory equipment - Heat - -
and moisture exchangers (HMEs) for
humidifying respired gases in humans
Part 2: HMEs for use with tracheostomized
patients having minimum tidal volumes of
250 ml


5)
ISO 9703-1 1992 Anaesthesia and respiratory care alarm - -
signals
Part 1: Visual alarm signals


5)
ISO 9703-2 1994 Anaesthesia and respiratory care alarm - -
signals
Part 2: Auditory alarm signals



2)
ISO 4135:1995 is superseded by ISO 4135:2001, Anaesthetic and respiratory equipment - Vocabulary
3)
ISO 7396:1987 is superseded by ISO 7396-1:2002 and ISO 7396-2:2000, Medical gas pipeline systems
4)
ISO 7767:1997 and ISO 9918:1993 are superseded by ISO 21647:2004, which is harmonized as EN ISO 21647:2004, Medical
electrical equipment -- Particular requirements for the basic safety and essential performance of respiratory gas monitors.
5)
The ISO 9703 series is superseded by IEC 60601-1-8:2003, which is harmonized as EN 60601-1-8:2004.

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EN 60601-2-12:2006 - 6 -
Publication Year Title EN/HD Year
5)
ISO 9703-3 1998 Anaesthesia and respiratory care alarm - -
signals
Part 3: Guidance on application of alarms


3)
ISO 9918 1993 Capnometers for use with humans - - -
Requirements


6)
ISO 9919 1992 Pulse oximeters for medical use - - -
Requirements


ISO 11134 1994 Sterilization of health care products - - -
Requirements for validation and routine
control - Industrial moist heat sterilization


ISO 11135 1994 Medical devices - Validation and routine - -
control of ethylene oxide sterilization


ISO 11137 1995 Sterilization of health care products - - -
Requirements for validation and routine
control - Radiation sterilization


ISO 11138-1 1994 Sterilization of health care products - - -
Biological indicators
Part 1: General


ISO 11138-2 1994 Sterilization of health care products - - -
Biological indicators
Part 2: Biological indicators for ethylene oxide
sterilization


ISO 11138-3 1995 Sterilization of health care products - - -
Biological indicators
Part 3: Biological indicators for moist heat
sterilization


ISO 14971 2000 Medical devices - Application of risk - -
management to medical devices


ISO 15223 2000 Medical devices - Symbols to be used with - -
medical device labels, labelling and
information to be supplied



Annex ZB
(informative)

References to international publications
with their corresponding European publications

Publication Year Title EN/HD Year
Delete the reference to IEC 601-1:1977 from Annex ZB of EN 60601-1:1990/A2:1995

Replacement in Annex ZB of EN 60601-1:1990/A2:1995:


ISO 8185 1997 Humidifiers for medical use - General - -
requirements for humidification systems


6)
ISO 9919:1992 is superseded by ISO 9919:2005, Medical electric equipment - Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use.

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- 7 - EN 60601-2-12:2006
Annex ZZ
(informative)

Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
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INTERNATIONAL IEC
STANDARD
60601-2-12
[ISO 10651-1]
Second edition
2001-10
Medical electrical equipment –
Part 2-12:
Particular requirements for the safety of lung
ventilators – Critical care ventilators
Appareils électromédicaux –
Partie 2-12:
Règles particulières de sécurité pour ventilateurs
pulmonaires – Ventilateurs pour utilisation en soins intensifs
 IEC 2001  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in 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
PRICE CODE
X
For price, see current catalogue

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– 2 – 60601-2-12 © IEC:2001(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
SECTION ONE – GENERAL
1 Scope and object .7
2 Terminology and definitions .8
3 General requirements .12
4 General requirements for tests.12
5 Classification .12
6 Identification, marking and documents .12
7 Power input .16
SECTION TWO – ENVIRONMENTAL CONDITIONS
8 Basic safety categories .16
9 Removable protective means .16
10 Environmental conditions .16
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General .17
14 Requirements related to classification .17
15 Limitation of voltage and/or energy.17
16 ENCLOSURES and PROTECTIVE COVERS.17
17 Separation.18
18 Protective earthing, functional earthing and potential equalization.18
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.18
20 Dielectric strength.18
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.18
22 Moving parts.18
23 Surfaces, corners and edges .18
24 Stability in NORMAL USE.18
25 Expelled parts.18
26 Vibration and noise .18
27 Pneumatic and hydraulic power.19
28 Suspended masses .19
SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 X-radiation.19
30 Alpha, beta, gamma, neutron radiation and other particle radiation .19
31 Microwave radiation .19
32 Light radiation (including lasers).19
33 Infra-red radiation .19
34 Ultra-violet radiation.19

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60601-2-12 © IEC:2001(E) – 3 –
35 Acoustical energy (including ultrasonics) .19
36 Electromagnetic compatibility.19
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and basic requirements .20
38 Marking, ACCOMPANYING DOCUMENTS .20
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT .20
40 Requirements and tests for CATEGORY AP EQUIPMENT, parts and components thereof.20
41 Requirements and tests for CATEGORY APG EQUIPMENT, parts and components thereof .20
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.20
43 * Fire prevention .20
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility .21
45 Pressure vessels and parts subject to pressure.21
46 Human errors .22
47 Electrostatic charges .22
48 Biocompatibility.22
49 Interruption of the power supply .22
SECTION EIGHT – ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.23
51 Protection against hazardous output .24
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions.26
53 Environmental tests .26
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General .27
55 ENCLOSURES and covers .27
56 Components and general assembly.27
57 MAINS PARTS, components and layout.29
58 Protective earthing – Terminals and connections.30
59 Construction and layout .30
Appendix L References – Publications mentioned in this standard .31
Annex AA (informative) Rationale .34
Annex BB (normative) Legibility and visibility of visual indications .39
Annex CC (informative) Intelligent alarm systems .40
Bibliography .41
Terminology – Index of defined terms.42

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– 4 – 60601-2-12 © IEC:2001(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-12: Particular requirements for the safety of lung ventilators –
Critical care ventilators
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, 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 specifications, 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 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. IEC shall not be held responsible for identifying any such patent rights.
International Standard IEC 60601-2-12 has been prepared by subcommittee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
ISO TC 121/SC 3, Lung ventilators and related equipment, also participated in the preparation
of this standard.
This second edition replaces the first edition of IEC 60601-2-12:1988, Medical electrical
equipment – Part 2: Particular requirements for the safety of lung ventilators for medical use,
and ISO 10651-1:1993, Lung ventilators for medical use – Part 1: Requirements.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/414/FDIS 62D/440/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annex BB forms an integral part of this standard.
Annexes AA and CC are for information only.

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60601-2-12 © IEC:2001(E) – 5 –
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– notes, explanations, advice, introductions, general statements and references: smaller roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 60601-1 OR IN THIS PARTICULAR
STANDARD: SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2004. At this date, the publication will be:
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
NOTE IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for safety – Collateral
Standard: General requirements and guidelines for the application of alarms in medical electrical equipment is
currently under development. This Standard will require maintenance to conform to that Collateral Standard.

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– 6 – 60601-2-12 © IEC:2001(E)
INTRODUCTION
Critical care VENTILATORS are an essential medical device in every intensive care unit (ICU).
Approximately half of all PATIENTS in ICUs receive partial to full ventilatory support with this
EQUIPMENT. Given the vulnerable status of these PATIENTS, EQUIPMENT safety is of fundamental
importance. Accordingly, this Particular Standard, by building on other standards and
specifically on IEC 60601-1: Medical electrical equipment – Part 1: General requirements for
safety, herein referred to as the “General Standard”, sets the minimum requirements that
should be met by every critical care VENTILATOR that is designed after the publication of this
Particular Standard.
A rationale for the most important requirements is given in Annex AA.
Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, support-
care VENTILATORs, anaesthesia, emergency and transport VENTILATORs, jet and high frequency
VENTILATOR and oscillators are not covered by this Particular Standard, nor are devices that
may be used within hospitals, intended solely to augment the ventilation of spontaneously
breathing PATIENTS.

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60601-2-12 © IEC:2001(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-12: Particular requirements for the safety of lung ventilators –
Critical care ventilators
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 specifies the safety requirements for VENTILATORS, as defined in
2.1.125, intended for use in critical care settings.
Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, support-
care VENTILATORs, emergency and transport VENTILATORs, jet and high frequency VENTILATORs
and oscillators are outside the scope of this Particular Standard, nor are devices that may be
used within hospitals, intended solely to augment the ventilation of spontaneously breathing
PATIENTS. Standards for other types of VENTILATORs, e.g. high frequency jet and oscillation
ventilators, are under consideration.
Requirements for VENTILATORs intended for anaesthetic applications are given in IEC 60601-2-13.
1.2 Object
Addition:
The object of this standard is to specify particular safety requirements for VENTILATORS
intended for use in critical care settings.
1.3 Particular standards
Addition:
This Particular Standard refers to IEC 60601-1:1988, Medical electrical equipment – Part 1:
General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2
(1995), herein referred to as the “General Standard”.
The General Standard takes into account a set of Collateral Standards:
IEC 60601-1-1:2000, Medical electrical equipm
...