prEN 50447
(Main)Active implantable medical devices - Particular requirements for Heart-Lung Machines (HLM)
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
Overview
The prEN 50447 standard, developed by the European Committee for Electrotechnical Standardization (CENELEC) Technical Committee 62, specifies particular requirements for active implantable medical devices known as Heart-Lung Machines (HLM). These devices temporarily assume the pumping function of the heart and gas exchange function of the lungs during cardiopulmonary bypass procedures, ensuring the patient's vital functions are maintained. prEN 50447 is designed to supplement the general medical electrical equipment standard EN 60601-1 and addresses specific safety, performance, and operational considerations unique to HLMs.
While the standard was ultimately deleted from the work programme and cancelled due to lack of stakeholder interest, its content offers valuable insights into the safety requirements and functional features necessary for heart-lung machines used in medical practice.
Key Topics
Scope and Definitions
prEN 50447 covers heart-lung machines and related components such as arterial blood pumps, anticoagulation tubings, oxygenators, and protective devices designed to safeguard patients.Safety and Protective Devices
The standard emphasizes the need for protective devices that monitor critical parameters like blood pressure, temperature, air bubbles, blood level, and potential backflow. These devices must trigger audible and visible alarms and implement safety measures to avoid hazards like arterial backflow, air infusion, or reservoir emptying.Alarm and Warning Systems
Alarms must be both audible and visible with specified sound pressure levels and silence periods. Alarm override functions are allowed but must not compromise safety; persistent alarms must ensure the system returns to a safe state if ignored.Electrical Safety and EMC
Electrical protection includes patient leakage current measurements under defined test conditions and immunity to electromagnetic interference up to specified field levels, ensuring reliable operation in hospital environments.Mechanical and Environmental Considerations
Moving parts that could cause injury must be guarded, and the HLM must maintain stability under normal and additional load conditions. Environmental tests for abnormal operation and fault conditions are conducted to ensure robustness.Documentation and Instructions for Use
Detailed and clear user manuals are mandatory, highlighting the fail-live nature of HLMs, the importance of operator competence, potential safety hazards, and required operational checks before and during use.Performance Accuracy
Blood flow pumps must maintain accurate flow rates within manufacturer specifications using recommended tubing and oxygenators. Temperature monitors for blood and patient core temperature must meet defined accuracy thresholds, ensuring patient safety.
Applications
Cardiopulmonary Bypass Procedures
The standard applies to HLMs employed during surgeries requiring extracorporeal circulation, such as open-heart surgery. Compliance with these requirements enhances patient safety and device reliability.Design and Manufacturing of HLMs
Manufacturers can use the safety and performance criteria from prEN 50447 as guidelines for developing and testing heart-lung machines, ensuring compliance with electrical, mechanical, and operational standards.Hospital Medical Device Management
Healthcare facilities benefit from understanding these requirements to assess HLM equipment, validate instructions for use, and conduct proper staff training. The standard underscores the critical role of skilled perfusionists in the safe operation of HLMs.Quality Assurance and Regulatory Compliance
Though prEN 50447 was cancelled, its concepts support harmonization with EN 60601-1 and related standards, aiding regulators and certification bodies in evaluating device safety.
Related Standards
EN 60601-1 – General requirements for basic safety and essential performance of medical electrical equipment. prEN 50447 is intended as a particular standard supplementing EN 60601-1 for HLMs.
ISO 15675 – Specification for arterial line blood filters used in cardiopulmonary bypass, relevant to filter components addressed in prEN 50447.
EN 60529 – Degrees of protection provided by enclosures (IP code), referenced in requirements for water ingress protection (minimum IPX4 for HLM devices).
EN 12470 – Standards for clinical thermometers and temperature sensors, applicable to patient core temperature measurement devices integrated in HLM systems.
CEN/TC 251 – Data interface standards for health informatics, referenced concerning the data interface requirements in HLMs.
Keywords: Heart-Lung Machines, HLM, active implantable medical devices, cardiopulmonary bypass, medical device safety, protective devices, electrical safety, patient monitoring, medical equipment standards, EN 60601-1, CENELEC TC 62, medical device alarms, arterial pump, extracorporeal circuit, oxygenator, tubing set, perfusionist competency.
Frequently Asked Questions
prEN 50447 is a draft published by CLC. Its full title is "Active implantable medical devices - Particular requirements for Heart-Lung Machines (HLM)". This standard covers: 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
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
prEN 50447 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment; 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
prEN 50447 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase prEN 50447 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.
Standards Content (Sample)
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
- 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
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
- 5 - prEN 50447:2004
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
- 7 - prEN 50447:2004
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 interru
...
The prEN 50447 standard, which focuses on active implantable medical devices, specifically addresses the particular requirements for Heart-Lung Machines (HLM). The scope of this standard is crucial as it aims to outline the necessary specifications and safety measures that are essential for the effective operation of heart-lung machines, an integral component in life-support situations during surgical procedures. One of the significant strengths of prEN 50447 lies in its comprehensive approach to safety and efficacy in medical devices. The standard promotes high-quality benchmarks that must be met by manufacturers, thus ensuring that these critical devices are both reliable and safe for patient use. In the context of active implantable medical devices, this standard sets forth a framework that manufacturers can refer to in order to develop equipment that adheres to stringent safety guidelines, ultimately aiming to enhance patient outcomes. Furthermore, prEN 50447 remains relevant given the ongoing developments in medical technology. As heart-lung machines evolve, the necessity for updated standards that address new risks and technological advancements remains paramount. Even though the standard faced challenges in its project timeline due to a noted lack of sustained interest from stakeholders, its deletion from the work programme does not diminish its importance. The specifications provided by prEN 50447 can still serve as a reference point for ongoing discussions among medical device manufacturers, regulatory bodies, and healthcare professionals. The cancellation of the project, coupled with the decision to release the standstill, highlights a potential opportunity for renewed dialogue regarding the standardization of heart-lung machines. Stakeholders might reconsider the importance of establishing a relevant framework, as the complexities involved in active implantable devices require ongoing collaborative efforts to ensure the highest standards of safety and performance. In conclusion, while prEN 50447 may not currently be active in the standardization pipeline, its scope and inherent strengths underscore the relevance of developing robust guidelines tailored to the unique challenges posed by heart-lung machines. As such, it serves as a pivotal document for future advancements in medical technology and patient care related to active implantable medical devices.
標準 prEN 50447 は、心肺機械（HLM）に特化した医療機器であるアクティブインプラント機器のための特定要件に関するものです。この規格の範囲は、心肺装置の設計、製造、試験における重要な要素を定義しており、医療分野における安全性と有効性を確保するための基盤を提供しています。 この標準の強みは、医療機器の使用におけるリスクを低減し、患者の安全を確保するための具体的で明確な指針を示している点です。特定要件が詳細に規定されていることで、メーカーは製品開発において必要な基準を容易に把握し、遵守することができます。また、このような標準化は、製品の品質向上や市場での競争力を高めることにも寄与しています。 さらに、prEN 50447 の関連性は、医療技術の進化に伴い心肺機械の重要性が高まる中で、ますます明確になっています。特に、患者ケアの向上に向けた取り組みが求められている現代において、この標準が提供する基準は、医療従事者と製造者双方にとって不可欠な参考資料となっています。 総じて、prEN 50447 は、心肺機械に関わるすべての利害関係者にとって価値ある標準であり、その具体的な要件は、安全性と効率性を兼ね備えた医療機器の開発を促進しています。
표준 문서 prEN 50447은 심폐 기계(HLM)에 대한 특정 요구사항을 다루고 있으며, 이 문서는 활발히 이식 가능한 의료 기기에 관한다. 이 표준의 범위는 심폐 기계의 안전성과 성능을 보장하기 위한 구체적인 요구사항을 정의하고 있어, 의료 기기 제조업체와 관련 기관에 큰 의미를 가진다. 이 표준의 주요 강점 중 하나는 심폐 기계에 특화된 요구사항을 제공하여 이 기기들이 환자의 생명을 직접적으로 다루는 만큼, 높은 신뢰성과 안전성을 확보할 수 있도록 돕는 것이다. 또한, prEN 50447은 기계의 설계 및 성능 기준을 명확하게 설정해, 의료 전문가들이 장비를 선택하고 사용할 때 유용한 지침을 제공한다. 이 문서는 유럽 내에서 의료 기기 관련 규제의 일관성을 높이고, 전 세계적으로도 표준화된 기계를 통해 환자 치료의 질을 향상시키는 데 기여할 수 있는 중요한 역할을 한다. 특히, 심폐 기계의 특정 특성을 고려한 요구사항을 포함함으로써, 후속 연구와 개발에도 단초를 제공할 수 있는 가치가 있다. 따라서 prEN 50447 표준은 심폐 기계를 포함한 이식 가능한 의료 기기에 대한 필수적이고 실질적인 기준으로서의 중요성을 잘 보여준다. 현재, 이해관계자들의 지속적인 관심 부족으로 인해 이 표준이 작업 프로그램에서 삭제된 사실은 아쉽지만, 향후 관련 연구와 관심이 재확대될 가능성을 배제할 수 없다.
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