An ISO guide 25 certified testing laboratory for clinical engineering education

An

I S 0

Guide 25 Certified Testing laboratory for Clinical Engineering

Education

'Chii-Wann Lin, 2Po-Quang Chen, 2Chin-Te Chen, 2Chung-Ming Lu, 2Jia-Hung Chien, 2Chiu-Hung Yang, 2Chun-Kai, Huang, 'Chang-Yi Wang, 'Yung-Zu Tseng, 'Hwa-Chang

Liu

'Institute of Biomedical Engineering, College of Medicine and College of Engineering, National Taiwan University

2Department of Biomedical Engineering, National Taiwan University Hospital

Abstract

The establishment of a certified I S 0 Guide 25 testing laboratory for medical devices is

an

important corner stone for a better national medical device management system and practices of the assorted standards or guidelines. It can also contribute significantly to the educational program for clinical engineer. As a starting point, a medical electrical safety-testing laboratory according to the AAMI ES-1 (1993) and IEC 60601 (1988) has

been setup and devoted to the safety of electromedical apparatus with joined efforts of the Institute of Biomedical Engineering, National Taiwan University and Department of Biomedical Engineering, National Taiwan University Hospital. To ensure its quality of services, ISO/IEC Guide 25 is implemented and certified by Chinese National Laboratory Accreditation (CNLA). In view of the global harmonization, this

painstaking procedure for a medical device-testing laboratory can be fruitful in the aspects of quality assurance for the imported devices and post-market surveillance. It also has positive impact on the infrastructure of domestic medical device regulation and development. In this report, we will discuss the necessary procedures to train a clinical engineer to account for this need.

Proceedings of the 22"d Annual EMBS International Conference, July 23-28, ;!OOO, Chicago IL.

Introduction

In the wake of globalization, the effectiveness of medical devices can be a potential probl'em for the general health care management system. The initiation of assorted vertical and horizontal standards and guidelines by various groups, such as International Standard Organization (ISO), International Electrotechnical Commission (IEC), American National Standard Institute (ANSI), and Association for the Advancement of Medical Instrumentation ( A M I ) , etc., can only stress the importance of minimal qualityassurance procedures. Even though a lot of these standards set far the scope of medical devices design and development, it is required for the medical device regulatiodmanagement system and law enhancement in some disputed cases. This poses a great demand on the educational program of biomedical engineering (BME), especially the clinical engineering (CE). As the existence of tremendous differences between R&D laboratories and CE department in a hospital, the training programs for

these two directions should emphasize the common needs, which are the importance of

regulations for the graduate students. These important aspects of career pi2th for a

B M E

and/or CE have been put into considerations to design courses in our newly established Graduate Institute of Biomedical Engineering at National Taiwan University [ 13.

The many faces of quality system can be quite confusing and tedious from the engineering point of views. There are ISO-9000 series, I S 0 Guide 25, and ISO-14000

for the general concerns of industrial requirements and Good Manufacture Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice l(GCP) for the specific concerns of medical device communities ranging from manufactures to the clinical applications. Even though, the essential elements of these quality systems are extremely similar, the practical solutions for each individual system can have different levels of sophistication during the implementation. These detailed implementations have to document in Standard Operating Procedure (SOP) and execute by qualified engineers. This represents both a management and technical challenges for BME and CE.

The establishment of a certified I S 0 Guide 25 testing laboratory for medical devices is an important comer stone for a better national medical device management system and practices of the assorted standards or guidelines. It can also contribute significantly to the educational program for CE. As a starting point, a medical electrical safety-testing laboratory according to the AAMI ES-1 (1993) and IEC 60601 (1988) has been setup and devoted to the safety of electromedical apparatus with joined efforts of the Institute of Biomedical Engineering, National Taiwan University and Department of Biomedical Engineering, National Taiwan University Hospital [. To ensure its quality of services, ISO/IEC Guide 25 is implemented and certified by Chinese National Laboratory Accreditation (CNLA). In view of the global harmaaization, this

painstaking procedure for a medical device-testing laboratory can be fruitful in the aspects of quality assurance for the imported devices and post-market surveillance. It

also has positive impact

on

the infrastructure of domestic medical device regulation and development with the supports from government (Department of Health, Executive Yuan) [3]. In this report, we will discuss the necessary procedures to train a clinical

Voltage 1O4-127Vm

Materials and Methods

Frequency Resistance Temperature Humidity Pressure 6001Hz

<=m

2305 0 50020 %RH 700 - 1060 mbar

The training program for a BME/CE to get acquainted with various standards and its practices can be time consuming and exhaustive in all aspects. For the education purpose, the needs to extract and condense the merits of these requirements are obvious. Some topics are identified as follows and should be addressed in the training program.

1. Bio-ethics

2. Background introduction of Standards and Regulations

3. Comparisons of Quality Systems

4. Requirements and Compliance of Quality Medical Devices 5. Regulations

For laboratories engaged in calibratiodtesting, the details of these topics have two major areas: quality management requirements and technical requirements. The key concept to fulfill quality management requirement is to: plan, do and audit. These requirements should be put in formal documents as quality manual, standard procedure/working instruction, and records for proper management. The technical issues of testing procedures really depend on the types of medical devices. As for an

electrical safety-testing laboratory, these include the compliance with environmental requirements (as shown in Table 1) and safety current limits (as shown in Table 2). The testing procedures can be either manual steps or automated via instrumentation control

[4]. The use of software should subject to the control of quality documents or product development cycle. The measurement traceability should be installed whenever is possible to ensure the accuracy or validity of services. The uncertainty in measurement should be analyzed and documented for the peer reviews of laboratory capability. The compliance of I S 0 Guide 25 has to be confirmed by internal and external auditing procedures. IEC CF NC 100 10 500 2500 5,000 SFC 500 50 1000 5000 10,000 BF NC 100 100 500 2500 5000 Classification 0-7803-6465-11001$10.00 02000 IEEE 2039

Proceedings of the 22"d Annual EMBS International Conference, July 23-28,2:000, Chicago IL.

B

SFC 500 500

NC 100 100 500 2500

SFC 500 500

After completing all the documentation and necessary training sessions, one can apply for the certification to any I S 0 Guide 58 certified institutes, which is Chinese National Laboratory Accreditation (CNLA) in Taiwan. The registration items, test items, test methods and range are listed as shown in Table 3. The certificate was awarded on Nov. 1, 1999 after one-year preparations.

/Registration ITest Items :est Methods /Range IBest Test Items ED0405 Electromedi cal for electrical safety capability Recognized Accuracy: 0 1% of readin ( 1993) Electrome dical apparatus

I

AAMIES105-4

:. IEC 11 .Enclosure leakage test, 10-5000 uA 101% of reading 1-1

(1988

)

2.Safety Ground Leakage test, 0-5000 UA 0196 of reading 3.Patient lead leakage test , 0 196 of reading

IEC60601019

EC60601019.1E, 19.2A, 19.3, 19.4

test

0-200 uA

4.Impedance of protective earth 0-20 ohms 0196 of reading EC60601018f

Discussions and Conclusions

The primary goal of this project is to further refine the infrastmucture of our

national management system for medical devices. To consolidate this idea, we are now trying to organize a union of certified medical device testing laboratory and dedicate to the quality assurance of both imported and domestic medical devices. To accommodate for the stringent needs of medical devices, a special requirement that take GLP into account will be incorporated in the near future. These include device classification, animdclinical test protocol, data handling, etc. Through the learning processes of establishment of an I S 0 Guide 25 certified laboratory, the accordance of BME and CE can be further enhanced by the activities of design, verification, modiification, and quality management system. It is a valuable experience to share with those who are interesting in such a program in the future.

Acknowledgement

This project is supported by Department of Health, Executive Yuan, Taiwan, R.O.C. (DOH 88-TD-1117).

References

1. Lin, C.-W., Tseng, Y.-Z., “Biomedical Engineering : A New Program Integrating Medicine and Engineering at National Taiwan University”, J. of Medical Education,

2. Lin, C.-W., Chen,

P.-Q.,

Chen, C.-T., Lu, C.-M., Chien, J.-H., Yang, C.-H., Huang, C.-K. “An Electromedical Safety Testing Laboratory in Compliance with I S 0 Guide 25”, Annual Meeting of Chinese Biomedical Engineering Society, Tainan, Taiwan, R.O.C., 1999

3. Lin. C.-W., Chen, C.-T., Chen, P.-Q,, Wang, C.-Y., Tseng, Y-Z., Liu, H.-C., ‘The

Refinement of Management System for the Testing of Medical Devices”, Annual Meeting of Chinese Biomedical Engineering Society, Tainan, Taiwan, R.O.C., 1999 4. Lin, C.-W., Feng, P., Tang, Y.-Y. and Tseng, Y.-Z., 1998, “An Electrical Safety

Analyzer for Standards of Electromedical Apparatus”. Biomed. Eng. Appl. Basis Comm., 10:151-155

2~429-436 (1999).