prEN 50447

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

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
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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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
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
suction device
device for sucking of blood and other liquids
2.112
temperature device
device for monitoring the temperature in the cardiopulmonary bypass and/or to PATIENT, comprising of
a sensor, an alarm and a display
2.113
heater/cooler device
device for maintaining, reducing or increasing the body core temperature by controlling the blood
temperature in the EXTRA-CORPOREAL CIRCUIT
2.114
data interface
normative reference to CEN/TC 251
2.115
protective device
means which senses a specified parameter (or parameters) or a constructional feature specifically
designed to protect the PATIENT against SAFETY HAZARDS which may arise
2.116
tubing set
means for connecting the functional parts of the HLM with each other and the PATIENT'S circulation by
TEMPERATURE DEVICE, HEATER/COOLER DEVICE, PROTECTIVE DEVICE, to the HLM
2.117
venous return flow set
means to adjust the venous back flow from the PATIENT
Draft for Enquiry
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2.118
extracorporal circuit
blood circuit between venous and arterial blood access points
2.119
arterial line blood filter
accessory device used as part of the cardiopulmonary bypass system in the atrerial blood return line
for filtering particles such as blood clots, debris and gas emboli from the blood (see ISO 15675)
3 General requirements
This clause of the General Standard applies except as follows:
3.6 Addition :
3.6 ja) Failure of a PROTECTIVE DEVICE (see 51.112)
3.7.101 Air in the TUBING SET
4 General requirements for tests
This clause of the General Standard applies in full.
5 Classification
This clause of the General Standard applies except as follows:
5.3 Addition:
HLM shall have a minimum IPX4 degree of protection against ingress of water (see EN 60529).
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.8.2 Instruction for use
Addition:
aa) The instructions for use shall additionally:
1) contain information that the HLM is a fail live system and its safe use cannot be
ensured by technical means only. Therefore the knowledge and skills of the
perfusionist are crucial (see Annex AA);
2) if applicable, contain a statement regarding the connection of the POTENTIAL
EQUALISATION CONDUCTOR;
3) draw the attention of the OPERATOR to the potential SAFETY HAZARD arising from
improper connection of the TUBING SET;
4) draw the attention of the OPERATOR to the potential SAFETY HAZARD arising from
improper use of the HLM;
Draft for Enquiry
5) contain a statement that the mechanical stability of the HLM may be impaired if the
limits of the stated SAFE WORKING LOAD are exceeded;
6) if applicable, describe at least one method of setting the occlusion;
7) draw attention to the safety hazards caused by setting the wrong occlusion;
8) describe safety hazards caused by incorrect connection to the gas supply unit;
9) describe the adjustment of the alarm limits for each PROTECTIVE DEVICE;
10) contain a description of the tests necessary to check the integrity of TUBING SET;
11) draw the attention of the OPERATOR to the precautions necessary to check the
proper function of the HLM prior to use;
12) describe the safety hazards caused by incorrect selection of the TUBING SET
diameter;
13) Contain a statement that proper blood oxygenation has to be checked using an
independent means (e.g. measurement of blood gases or oxygen saturation);
14) provide all data interface information;
15) explain the procedure to be used in the case of an ARTERIAL PUMP accidental stop;
16) explain at least one method of removing air from the arterial line;
17) if applicable, contain information regarding the flow rate accuracy for each
recommended tubing set.
Compliance is checked by inspection.
6.8.3 Technical description
Addition:
The technical description shall additionally:
1) describe the particular measures to be taken or conditions to be complied with when installing the
HLM or bringing it into service. This shall include guidance on the type and number of tests to be
performed;
2) describe the range of sound pressure level of any adjustable audible alarm source;
3) describe the audible alarm silence period;
4) describe the override time(s) for any PROTECTIVE DEVICE;
5) recommend that the HLM is connected to an uninterruptible power source.
Compliance is checked by inspection.
Section 2 - Environmental conditions
The clauses and subclauses of this section of the General Standard apply.
Draft for Enquiry
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Section 3 - Protection against electric shock hazards
The clauses and subclauses of this section of the General Standard apply except as follows:
19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY CURRENTS
19.4 Tests
Addition:
h) Measurement of the PATIENT LEAKAGE CURRENT
101) Measurement of the PATIENT LEAKAGE CURRENT shall be made from the APPLIED PART filled with
saline solution.
The point of measurement shall be where the APPLIED PART lines are connected. For the duration of
the test, a test solution with a conductivity of (13,5 ± 0,5) mS/cm at a temperature of 25 °C shall be
flowing in the APPLIED PART circuit. The EQUIPMENT shall be fully equipped for the intended use as
specified by the manufacturer.
Section 4 – Protection against mechanical hazards
The clauses and subclauses of this section of the General Standard apply except as follows:
22 Moving parts
22.4 Amendment:
Moving parts of the HLM which may cause physical injury to the OPERATOR/perfusionist shall be
guarded by shielding which can only be removed by intentional operation.
Compliance is checked by inspection.
24 Stability in NORMAL USE
Requirements for additional loads under consideration.
Section 5 – Protection from unwanted or excessive radiation
The clauses and subclauses of this section of the General Standard apply except as follows:
36 Electromagnetic compatibility
Addition:
36.101 Immunity
If the HLM is exposed to a radiated radio frequency electromagnetic field, the HLM shall
a) continue to perform its intended function as specified by the manufacturer up to and including a
radiated electromagnetic field level of 3 V/m; and
b) continue to perform its intended function as specified by the manufacturer or fail without creating
runaway/change of pump direction at a radiated electromagnetic field level of up to 10 V/m.
Draft for Enquiry
Section 6 – Protection against hazards flammable anaesthetic mixture ignition
The clauses and subclauses of this section of the General Standard apply.
Section 7 – Protection against excessive temperatures and other SAFETY HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
46 Human errors
Addition:
NOTE The essential purpose of the HLM is to maintain blood circulation to the PATIENT and the competance of the perfusionist
is paramount to the safe operation of the HLM.
49 Interruption of the power supply
This clause of the General Standard applies except as follows:
Addition:
49.101 In the event of a POWER SUPPLY interruption of the to the HLM, the following safe
conditions shall be achieved:
a) an audible alarm shall be activated, for at least 1 min;
b) it shall be possible to operate the ARTERIAL PUMP using an alternative power supply source or by
manual means.
Compliance is under consideration.
Section 8 – Accuracy of operating data and protection against hazardous output
This clause of the General Standard applies except as follows:
50 Operating data accuracy
50.2 Control and instrument accuracy
Addition:
The ARTERIAL PUMP shall produce the blood flow specified by the manufacturer over the specified
operating range using the recommended TUBING SET AND OXYGENATOR.
Compliance is checked by volumetric measurement.
50.2.101 The accuracy of the blood TEMPERATURE DEVICE in the HLM shall be ± 0,5 °C or better.
Compliance is checked by taking a reference measurement in the fluid next temperature sensor.
50.2.102 If the device for measuring the patient core temperature is part of the HLM it shall be in
1)
accordance with EN 12470 .
———————
1)
At draft stage.
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50.2.103 The accuracy of any measuring device used in an EXTRACORPORAL CIRCUIT shall be
better than ± 5 % at any measurement point throughout the device operating range.
51 Protection against hazardous output
This clause of the General Standard applies except as follows:
51.2 Indication of parameters relevant to safety
Addition:
51.2.101 If the HLM can be used in different operational modes, the selected mode shall be
OPERATOR.
obvious to the
Compliance is checked by inspection.
51.2.102 The HLM shall be equipped with a PROTECTIVE DEVICE independent of any temperature
control device which prevents a blood temperature greater than 41 °C when measured in the TUBING
SET on the blood side of the heat exchanger.
Operation of the PROTECTIVE DEVICE shall achieve the following safe conditions :
a) activation of an audible/visible alarm;
b) switching off the heating device.
51.2.103 The HLM shall include a PROTECTIVE DEVICE to prevent arterial back flow after an ARTERIAL
PUMP stop.
51.2.104 Tubing set blood loss
The HLM shall include a PROTECTIVE DEVICE to protect the EXTRACORPORAL CIRCUIT from pressures
exceeding the rated value of any of its components.
Operation of the PROTECTIVE DEVICE shall achieve the following safe conditions:
a) activation of a audible/visible alarm;
b) stopping or slowing of the ARTERIAL PUMP.
51.2.105 Arterial pressure
The HLM shall include a PROTECTIVE
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