oSIST prEN 50447:2005

SLOVENSKI oSIST prEN 50447:2005

PREDSTANDARD
februar 2005
Aktivni medicinski pripomočki za vsaditev – Posebne zahteve za aparate srce-
pljuča (HLM)
Active implantable medical devices - Particular requirements for Heart-Lung
Machines (HLM)
ICS 11.040.40 Referenčna številka
oSIST prEN 50447:2005(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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DRAFT
EUROPEAN STANDARD prEN 50447
NORME EUROPÉENNE
EUROPÄISCHE NORM December 2004

ICS 11.040.10; 11.140


English version


Active implantable medical devices -
Particular requirements for Heart-Lung Machines (HLM)


(to be completed) Medizinische elektrische Geräte -
Besondere Anforderungen für die
Sicherheit von Herz-Lungen-Maschinen
(HLM)


This draft European Standard is submitted to CENELEC members for CENELEC enquiry.
Deadline for CENELEC: 2005-06-10

It has been drawn up by Technical Committee CENELEC TC 62.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CENELEC 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, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

Warning : This document is not a European Standard. It is distributed for review and comments. It is
subject to change without notice and shall not be referred to as a European Standard.

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


© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Project: 6877 Ref. No. prEN 50447:2004 E
Draft for Enquiry

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prEN 50447:2004 - 2 -

Foreword
This draft European Standard was prepared by the Technical Committee CENELEC TC 62, Electrical
equipment in medical practice . It is submitted to the CENELEC enquiry.
This draft European Standard is to be read in conjunction with EN 60601-1. Where the "General
Standard" is quoted, this means a reference to the latest version of EN 60601-1.
Subclauses which are additional to those in EN 60601-1 are numbered starting from 101.

_________________
Draft for Enquiry

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- 3 - prEN 50447:2004
Section 1 - General
1 Scope and object
This clause of the General Standard applies except as follows:
Addition:
This particular Standard applies to HEART-LUNG-MACHINES (HLM) as defined in 2.104, hereinafter
referred as HLM.
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Replacement:
2.1.5
applied part
the TUBING SET and or all parts permanently and conductivity connected to it and/or to the PATIENT
Addition:
2.101
arterial blood pump
the pump for transportation of blood in an EXTRA-CORPOREAL CIRCUIT
2.102
pressure monitoring
device for monitoring pressure, consisting of a sensor, alarm and display
2.103
gas flow device
device for the setting/display of a constant volume gas flow
2.104
heart lung machine (HLM)
device which, partially or totally, takes over the pumping function of the heart and the gas exchange
function of the lungs for a short time in order to maintain the vital functions of the body, hereinafter
referred to as HLM
2.105
console
the base unit for the reception of the functional units and the ACCESSORIES of the HLM
2.106
air detector
means for the detection of air bubbles consisting of a sensor and an alarm
Draft for Enquiry

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prEN 50447:2004 - 4 -

2.107
level monitoring
device for monitoring a specified liquid level, consisting of a sensor and alarm
2.108
oxygenator
device for the purpose of replacing the gas exchange function of the lungs
the content is in accordance with the definition shown in 3.1 of EN 12022
2.109
pump for cardioplegic solutions
means for the transportation of cardioplegic solutions
2.110
suction pump
pump which enables suction by creating low pressure
2.111
suct
...