Medical device standards provide many benefitsto manufacturers and users of medical devices.Compliance with these standards is necessary toallow companies to market their devices. Stan-

dards contain requirements that affect the way medical de-vices are designed, developed, and tested. Students inbiomedical engineering senior design courses need to bemade aware of these standards and understand their impact onthe design process for medical devices. They need to appreci-ate the value of considering them early in the design phase of aproject. This article discusses how medical device standardseducation can be incorporated into senior design courses.

Standardizing Many StandardsPrior to 1998, international medical device regulatory compli-ance was a complicated and confusing business. Every coun-try had different requirements for registration of medicaldevices before they could be sold, most of which were lessstrict than the U.S. Food and Drug Administration (FDA) reg-istration requirements. This was especially true for very inno-vative or revolutionary devices that were consideredexperimental in the United States. Because of this, it was ben-eficial for manufacturers to seek European approval beforeFDA clearance, and new medical technology was often firstavailable outside the United States.

European countries each had their own particular regula-tory schemes with their own particular emphasis. For exam-ple, the United Kingdom performed factory inspections withemphasis on manufacturing area or cleanroom environmentalcontrol. Belgium required a “pharmacist” located in Belgiumto assess a product’s sterility. Italy had extremely low allow-able levels of residual sterilant. Some countries, such as Ire-land and The Netherlands, had virtually no regulatoryrequirements at all. Each of these European regulatory agen-cies operated at its own pace for completing the approvals.Some countries would approve an application in six months;others in two years. By the time regulatory approval through-out Europe was completed, it was conceivable that a productdesign could have become obsolete.

This all changed in 1998 with the implementation of theEuropean Medical Device Directives to support the establish-ment of the European Union. The Directives are a unified lawgoverning the medical device approval process in each of the

member countries of the European community. A manufac-turer can now obtain simultaneous approval in all of Europewith a single application.

The Use of Standards in Medical Device DesignThe foundation of the European regulatory scheme is compli-ance with standards. A standard is a document issued by a pro-fessional organization that attempts to define a process or anattribute. The European approach is to use standards to assurethat a device design is safe and effective for its intended use.The standards are intended to assure that the device was de-signed according to established principles, design documen-tation was maintained and evaluated, and the performanceattributes of the device were measured according tostandardized methodology.

Among the variety of organizations that develop and main-tain standards relating to the design of medical devices are theInternational Organization for Standardization (ISO), the In-ternational Electrotechnical Commission (IEC), the Ameri-can Society for Testing and Materials (ASTM), theAssociation for the Advancement of Medical Instrumentation(AAMI), and the European Committee for Standardization(CEN).

Most standards are developed through a consensus of peo-ple involved in the development of the standard. Committeesassigned with the task of developing standards for medical de-vices typically consist of technical experts in medicine andengineering, product users, representatives of manufacturersand regulatory agencies, and interested third parties. Stan-dards provide many benefits to medical device designers,manufacturers, and users. They help ensure compatibilityamong components produced by different manufacturers,they prevent accidental misuse, and they ensure that attributesassociated with device safety and effectiveness are properlyevaluated.

Standards applicable to medical devices can be groupedinto three categories: process standards, standard test meth-ods, and performance standards.

Process Standards—These are standards that describe a gen-eral system or a way of doing things. The most important stan-dard of this type is ISO 9001:2000 Quality ManagementSystems—Requirements. This standard specifies the controls

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and methods to be used to manage almost all aspects of a man-ufacturing business, including how to establish and maintaindesign documentation, purchasing of raw materials, manufac-turing quality control, maintenance of manufacturing equip-ment, product servicing, and employee training [1]. Thesection on design controls is the most relevant for a new prod-uct design team. This section requires that the design team es-tablish and document the product’s design requirements,evaluate potential design hazards, establish finished devicespecifications and assure correct transfer of the specificationsthroughout large-scale manufacturing operations.

Standard Test Methods—These standards specify test proto-cols to be followed to evaluate the physical properties or per-formance levels of a product. Some of these standards specifyonly the format and manner in which the test is to be per-formed to enable fair comparison between devices while oth-ers specify both the test method and the criteria for acceptableresults. Important examples of these standards are the IEC60601 series standards [2], which specify tests for electricalsafety and electromagnetic compatibility, and the ISO 10993series standards [1], which specify test methods and accep-tance criteria for evaluating material biocompatibility.

Performance Standards—These standards describe perfor-mance attributes, usually for a single device category, such aspacemakers, wheelchairs, vascular catheters, and lasers. Per-formance standards often reference other standards when de-scribing the attributes a product must have. For example, theISO 10555 series of standards for intravascular catheters statesthat the catheter materials must meet the biocompatibility re-quirements of the ISO 10993 series standards [1].

Standards affect how a medical device is designed. Thus, therequirements specified by standards need to be considered duringthe early design phase of a new product. Two of the main objec-tives of a biomedical engineering senior design course are to teachstudents about the design process and prepare them for careers inbiomedical engineering. As part of a senior design course, stu-dents should identify standards that are relevant to the product be-ing designed, incorporate the requirements during the designphase, and evaluate the final product according to the methodol-ogy defined in the standards.

To illustrate the extent to which standards affect medicaldevice design, it is helpful to consider the standards that areapplicable to the design of a particular device. For example,we will describe the standards applicable to the design of an

intravascular catheter. This is a device used to inject a contrastagent into blood vessels to enable visualization under X ray.The device consists of a long plastic tube that is passedthrough a puncture in the skin and threaded through the bloodvessels. It is usually in the patient for less than one hour. It issterilized by ethylene oxide gas and individually packaged.

The following standards were used in the design and man-ufacturing processes for this intravascular catheter and con-formance to these standards was cited in order to gainEuropean regulatory approval.

Process StandardsISO 9001:2000 Quality Management Systems—Requirements

This standard specifies the controls and methods to be usedto manage almost all aspects of a manufacturing business. Thesection on design controls requires that the design team estab-lish and document the product’s design requirements, evalu-ate potential design hazards, establish finished devicespecifications, and assure transfer to production [1].

EN 46001:1995 Quality Management Systems for MedicalDevices

This contains special requirements specifically for manag-ing a medical device manufacturing business such as estab-lishing the product shelf life and maintenance of sterility [3].

EN 1441:1997 Medical Devices—Risk AnalysisThis standard specifies a procedure performed throughout

the design process to investigate the safety of a medical deviceby identifying hazards and estimating the risks associatedwith the hazards [3].

ISO 11135:1994 Medical Devices—Validation and RoutineControl of Ethylene Oxide Sterilization

This describes the procedures used to validate that the ster-ilization conditions will render the product sterile [1].

BS 5295:1989 Environmental Cleanliness in Enclosed SpacesThis specifies the conditions to assure the cleanliness of

the manufacturing environment [4].

Standard Test MethodsISO 10993-1:1997 Biological Evaluation of Medical De-vices—Part 1: Evaluation and Testing

This standard specifies material safety tests and accep-tance criteria that must be satisfied for a device to be consid-ered biocompatible [1].

Standards education can be

incorporated into senior design

courses and projects through lectures,

outside reading, Internet research, and

a standards search.

ISO 10993-7:1995 Biological Evaluation of Medical De-vices—Part 7: Ethylene Oxide Sterilization Residuals

This defines special tests to assure that products do notcontain toxic by-products of the sterilization process [1].

Performance StandardsISO 10555:1995 Sterile, Single-Use Intravascular Cathe-ters—Part 1: General Requirements

This document describes important performance require-ments for intravascular catheters, such as how catheter sizesare to be designated, acceptable surface condition, test meth-ods for corrosion resistance, force at break, liquid leakage un-der pressure, and air leakage into hub assembly duringaspiration [1].

EN 980:1999 Graphical Symbols for Use in the Labeling ofMedical Devices

This provides a set of international symbols that eliminatethe need to provide multilingual product information on med-ical device package labels [3].

EN 868-1:1997 Packaging Materials and Systems for MedicalDevices Which are to be Sterilized—Part 1: General Require-ments and Test Methods

This standard assures that packaging is compatible withthe sterilization process and effective at maintaining sterilitythroughout the product’s shelf life [3].ISO 594-2:1998 Conical Fittings with a 6% Luer Taper forSyringes, Needles, and Certain Other Medical Equip-ment—Part 2: Lock Fittings

This specifies the dimensions of standardized fittings thatassure the catheter is compatible with other devices withwhich it is used, such as syringes [1].

EN 1041:1998 Information Provided by the Manufacturerwith Medical Devices

This standard specifies the type of information the manu-facturer must provide with the device to assure that it is safelyand effectively used [3].

Due to the prevalence of medical device standards, the useof these standards is gradually being recognized and acceptedby the FDA. However, at this time, compliance with thesestandards is not required by the FDA for clearance to market amedical device in the United States.

Resources for StandardsInformation on applicable, relevant standards regarding thedesign, development, testing, and commercialization of medi-cal devices can be obtained from the various standards devel-opment organizations [1]–[8].

Standards Education in Senior Design CoursesIn the early design phases of a senior design project, many pro-ject teams conduct a patent search to determine if any prior art re-lating to their potential design solutions exists. Students shouldalso conduct a search of existing standards that may apply totheir design projects. This is a good practice that they can imple-ment when designing products for medical device companies.The benefit of doing this during the early design phase is that aproject team can identify the functional and performance re-quirements of their design and the required tests and test meth-ods specified by the applicable standards. Knowing this earlyallows a team to plan for the appropriate tests and eliminate de-signs that might not comply with the standards. This helps theteam focus their efforts and allows the development of morecomplete, accurate project schedules.

Standards education can be incorporated into senior de-sign courses and projects through lectures, outside read-ing, Internet research, and a standards search aspreviously described. Lecture topics could include therole of standards in medical device design and testing. Ac-tual standards could be presented, described, and ex-plained to students as part of a lecture on standards. Thiscould be followed with a discussion of the meaning of thestandard and its impact on medical device design and test-ing. Students could be required to find at least one stan-dard that is applicable to their design project. They couldconduct the appropriate tests specified by the standardthat are within the capabilities of their academic institu-tion. They could also be required, as part of the course, toshow that their final design is in compliance with the stan-dard. This exercise would give them the experience offinding applicable standards, learning how to interpretthem, and determining the project activities needed to en-sure compliance with a standard.

ConclusionMedical device standards exist to ensure the health and safetyof users of medical devices. Compliance with these standardsis necessary to allow companies to market their devices do-mestically and internationally. Standards contain require-ments affecting the way medical devices are designed,

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JULY/AUGUST 2003116

Students in biomedical engineering

senior design courses need to

appreciate the need to consider

standards early in the design phase

of a project.

developed, and tested. Students in biomedical engineering se-nior design courses need to be made aware of these standards,understand how they affect product design and the product de-velopment process for medical devices, and appreciate theneed to consider them early in the design phase of a project.This can be accomplished by including medical devicestandards education in senior design courses.

Brian S. Kunst is vice president of regula-tory affairs and quality assurance forAngioDynamics, Inc., a medical devicemanufacturer located in Queensbury, NewYork. He earned a master’s degree in bio-medical engineering from Tulane Univer-sity and began his professional career at theU.S. Food and Drug Administration in

Washington, DC. Brian has served as a chief regulatory officialfor medical device manufacturers W.L. Gore and Associates inFlagstaff, Arizona, and Surgitek in Racine, Wisconsin, beforejoining AngioDynamics in 1995. Brian’s responsibilities in-clude obtaining international regulatory approval for the com-pany’s products, conducting clinical trials of investigationaldevices, and managing manufacturing quality control.

Jay R. Goldberg is currently the director of the HealthcareTechnologies Management Program, assistant professor of bio-medical engineering at Marquette University, and assistant ad-junct professor of biophysics at the Medical College ofWisconsin. He has 14 years of product development experience

with several medical device companies, in-cluding DePuy (Warsaw, Indiana), Baxter(Deerfield, Illinois), Surgitek (Racine, Wis-consin), and Milestone Scientific (Deerfield,Illinois), and is a registered professional en-gineer in Illinois and Wisconsin. Dr.Goldberg received his B.S. degree in generalengineering from the University of Illinois,

his M.S. degree in bioengineering from the University of Michi-gan, his M.S. in engineering management from NorthwesternUniversity, and his Ph.D. in biomedical engineering(biomaterials) from Northwestern University.

Address for Correspondence: Jay R. Goldberg, Director,Healthcare Technologies Management Program, Departmentof Biomedical Engineering, Marquette University, P.O. Box1881, Milwaukee, WI 53201 USA. Phone: +1 414 2886059.Fax: +1 414 288 6069. E-mail: jay.goldberg@mu.edu.

References[1] International Standards Organization. Available: http://www.iso.org

[2] 601help. The Medical Device Developer’s Guide to IEC 60601-1. Available:http://www.601help.com

[3] Directive 93/42/EEC. Available: http://www.europa.eu.int/comm/enter-prise/newapproach/standardization/harmstds/reflist/meddevic.html

[4] British American Chamber of Commerce. Available: http://www.baccsf.org

[5] New Approach Standardization in the Internal Market. Available:http://www.newapproach.org

[6] IHS Health Group. Available: http://www.ihshealthgroup.com

[7] Association for the Advancement of Medical Instrumentation. Available:http://www.aami.org

[8] ASTM International Standards Worldwide. http://www.astm.org

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JULY/AUGUST 2003 117

Learning Technologies to Foster Critical Reasoning(continued from page 57)

Lin Qiu is a Ph.D. candidate in computer science at North-western University. His research interests include human-com-puter interaction and artificial intelligence in intelligentlearning systems. He received his B.E. in computer science andengineering from Shanghai Jiao Tong University, China.

Baba Kofi Weusijana is a Ph.D. student in learning sciences atNorthwestern University. He is a member of the AmericanEducational Research Association (AERA), the AmericanSociety for Engineering Education (ASEE), the Brothers ofthe Academy (BOTA) Institute, the National Society of BlackEngineers (NSBE), and the National Coalition of Blacks forReparations in America (N’COBRA). He has a B.S. in mathe-matics from Dillard University and a B.S. in computer scienceand an M.S. in engineering (client/server computing with dis-tributed objects) from San Jose State University.

Joseph T. Walsh is a professor in biomedical engineering atNorthwestern University and associate dean for graduatestudies and research for the McCormick School of Engineer-ing and Applied Science. He received his Ph.D. in medical en-gineering from the Massachusetts Institute of Technology. Hisresearch involves analytic and experimental analysis of the in-teraction of laser radiation with tissue and the development ofdiagnostic and therapeutic applications of lasers.

Matthew Parsek is an assistant professor in the Departmentof Microbiology at the University of Iowa. He has a B.S. fromthe University of Illinois at Champaign-Urbana and a Ph.D.

from the University of Illinois at Chicago. His research fo-cuses on quorum sensing in bacterial communities.

Address for Correspondence: Christopher K. Riesbeck,Room 348, Computer Science, Northwestern University,1890 Maple Avenue, Evanston, IL 60201 USA. Phone: +1847 491 7279. E-mail: riesbeck@cs.northwestern.edu

References[1] J.D. Bransford, A.L. Brown, and R.R. Cocking, Eds., How People Learn; Brain,Mind, Experience, And School, Washington, DC: National Academy Press, 2000.[2] L. Qiu, C.K. Riesbeck, and M. Parsek, “Indie: A software tool for investigate and de-cide simulations,” presented at the Proc. Annu. Conf. Amer. Educ. Res. Assoc., 2002.[3] B.K. Weusijana, C.K. Riesbeck, and J. Walsh, “Enriching students’ laboratoryexperience: Using software and Socratic methods to foster reflective thought in anengineering laboratory,” in Proc. Amer. Soc. Eng. Educ., CD-ROM DEStech Publi-cations Session 3430, 2002.[4] W. Dobson and C. Riesbeck, “Tools for incremental development of educationalsoftware interfaces,” in CHI, pp. 384-391, 1998.[5] R. Schank, “Goal-based scenarios: A radical look at education,” J. Learning Sci.,vol. 3, pp. 54-60, July 1994.[6] A. Collins, J.S. Brown, and A. Holum. “Cognitive apprenticeship: Making think-ing visible,” Amer. Educator, pp. 6-46, Winter 1991.[7] A. Collins and A. Stevens, “Goals and methods for inquiry teachers,” in Ad-vances in Instructional Psychology, R. Glaser, Ed., Hillsdale, NJ: Erlbaum, 1982,vol. 2, pp. 65-119.[8] C.P. Rosé, D. Moore, K. VanLehn, and D. Albritton, “A comparative evaluationof Socratic versus didactic tutoring,” in Proc. 23rd Annu. Conf. Cognitive Sci. Soc.,Edinburgh, Scotland, Aug. 2001.[9] P.W. Jordan, C.P. Rosé, and K. VanLehn, “Tools for authoring tutorial dialogueknowledge,” in Proc. Artificial Intelligence in Education, Washington, DC, 2001,pp. 222-233.[10] D.C. Edelson, “The Socratic case-based teaching architecture: Learning fromquestions and cases,” in Inside Multi-Media Case Based Instruction, R.C. Schank,Ed., Hillsdale, NJ: Erlbaum, 1998, pp. 103-174.