EN 60601-2-12:2006

Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

Specifies the safety requirements for ventilators, as defined below, intended for use in critical care settings. Ventilator: automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient.

Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit von Beatmungsgeräten für den medizinischen Gebrauch - Beatmungsgeräte für die Intensivpflege

Appareils électromédicaux - Partie 2-12: Règles particulières de sécurité pour ventilateurs pulmonaires - Ventilateurs pour utilisation en soins intensifs

Complétant les règles générales de sécurité des appareils électromédicaux énoncés dans la publication de base, EN 601-1, établit des prescriptions spécifiques relatives aux ventilateurs pulmonaires qui comportent des dispositifs électriques conçus pour l'utilisation médicale.

Medicinska električna oprema – 2-12. del: Posebne varnostne zahteve za pljučne ventilatorje – Ventilatorji za kritično oskrbo (IEC 60601-2-12:2001)

General Information

• Status: Published
• Publication Date: 27-Jun-2006
• Withdrawal Date: 30-Apr-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 28-Jun-2006
• Completion Date: 28-Jun-2006
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-12:2006 - Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

Standards Content (Sample)

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
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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
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.
__________
- 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).

__________
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.

- 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.

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.

- 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.
___________
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.
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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 .
...