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
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
CAPI
...