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

D127/107: Project under Benchemark 6 * Extension of target date approved until 2007-09-12 (no more extension allowed) * TC 62 decision on 2006-10-24: prEN 50447 deleted from work programme due to lack of sustained interest from stakeholders * D129/C066: Cancellation of project confirmed * Standstill released

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

Dispositifs médicaux implantables actifs - Règles particulières pour coeur-poumon artificiel

Aktivni medicinski pripomočki za vsaditev – Posebne zahteve za aparate srce-pljuča (HLM)

General Information

Status
Not Published
Current Stage
2098 - Decision to drop project - Standstill maintained / released
Due Date
30-Oct-1996
Completion Date
24-Oct-2006

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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
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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.

_________________
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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
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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
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
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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;
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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.
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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.

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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 interru
...

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