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Received March 8, 2018, accepted March 8, 2018, date of publication March 25, 2018.

Certification in the United States, Canada and Asia

By James O. Wear

CeRtified BioMediCAl  
eqUipMent teChniCiAnS

The first certification in the US in the clinical engi-
neering field was for biomedical equipment technicians 
(BMETs).1–4 As biomedical equipment maintenance was 
developing in US hospitals in the late 1960s, there were 
no training programs for BMETs. A few 2-year techni-
cal schools initiated training programs based on their 
electronics curriculum, but there was no standardized 
curriculum. Even the electronic programs in these schools 
were not accredited nor had a standard electronic cur-
riculum. There were also BMETs that had been trained 
in the military.

The Association for the Advancement of Medical 
Instrumentation (AAMI) had a task force to look at the 
BMET field and the maintenance of medical equipment in 
hospitals. The task force decided that something needed 
to be done to allow BMETs to demonstrate that they had a 
minimum level of expertise. Certification of BMETs became 
the tool to demonstrate this minimum level of expertise. 
A Board of Examiners was established by AAMI and the 
first exam was given in 1970. Individuals who passed the 
written exam became Certified Biomedical Equipment 
Technicians (CBETs).

Certification was not readily accepted by BMETs or 
by the institutions hiring them. There also was an issue 
of testing sites and dates to allow BMETs to readily be 
tested without considerable travel expenses.

The Department of Veterans Affairs (VA) wanted to 
have its BMETs certified, but funds were not available 
to provide travel for them to go to the AAMI meeting for 
testing. In 1973, the VA developed its own BMET certi-
fication program from its Engineering Training Center.5 
The requirements to take the exam were the same as the 

AAMI and the exam was similar since the director of the 
VA Training Center was on the AAMI Board of Examin-
ers. The VA used the Human Resources Department at 
each hospital as a testing site since they were approved 
for giving other exams. The VA exam was developed by 
the VA Training Center faculty. In the VA, the technicians 
are called biomedical engineering technicians which is 
still BMET.

AAMI found a need to develop specialist exams for 
BMETs who worked on laboratory and radiological equip-
ment. These BMETs might not be able to pass the general 
exam since they only worked on special equipment, but 
they need certification to demonstrate a minimum level 
of expertise in their specialty. AAMI developed specialty 
exams in these two areas and individuals that passed 
these exams became Certified Radiological Equipment 
Specialists (CRESs) and Clinical Laboratory Equipment 
Specialists (CLESs). These three certification programs 
still exist today.

The VA also found the need to establish the radiologi-
cal specialty certification program and CRES. In 1984-5, 
the VA merged its certification program with the AAMI 
program. All VA certifications were accepted by the AAMI 
program and the VA allowed its Human Resources Offices 
to be used to give AAMI certification exams.

Individuals must meet the following qualifications to 
take the AAMI BMET certification exam:

• Associate’s degree in biomedical equipment technol-
ogy program and two years’ full-time

• BMET work experience; OR
• Completion of a U.S. military biomedical equipment 

technology program and two years’ full-time BMET 
work experience; OR

http://www.globalce.org
http://www.globalce.org


James O. Wear: Certification in the United States, Canada and Asia

J Global Clinical Engineering Special Issue 1: 15-22; 2018 16

• Associate’s degree in electronics technology and 
three years’ full-time BMET work experience; OR

• Four years’ full-time BMET work experience

The exam can be taken if a person has an associate 
degree in BMET or two-years’ experience full time as a 
BMET. If they pass the exam, they have five years to com-
plete the additional 2 years of full-time experience as a 
BMET to be certified. To take the CRES or CLES exam, a 
person must have worked at least 40% of the time in the 
past two years or 25% of the time in the past five years 
in the designated specialty area.

Each of the AAMI exams is 165 multiple-choice questions 
and is administered by a professional testing organization. 
The Board of Examiners creates questions for the exam 
bank and reviews new exams before they are used. The 
professional testing organization has responsibility for 
the exam security.

In the AAMI certification program over 3000 are 
CBETs, about 600 CRESs and around 100 CLESs. Every 
three years, individuals must renew their certification 
by demonstrating a certain amount of continuing educa-
tion to be maintained as a CBET, CRES or CLES. Most of 
the CBETs are in the United States, but BMETs in several 
other countries have taken the exam and become CBETs.

AAMI has placed all of their certification programs in 
their AAMI Credentials Institute (ACI). In 2016 the CBET, 
CLES and CRES became ANSI accredited under ISO/IEC 
17024 Personnel Certification.

Electronics Technicians Association International (ETA) 
also certifies BMET as both general medical equipment 
and radiological equipment technicians. They must be 
certified as Certified Electronics Technicians (CET) before 
they can take the journeyman certification exams. With 
six or more years of training and work experience in the 
field, the CET can take the journeyman exam. They must 
score 85% on the journeyman exam to be certified.6 If 
they pass the journeyman certification exam for medical 
equipment, they become CET-BMD. By passing the journey-
man certification exam for radiological equipment, they 
become CET-BIET.7 Their programs are aligned with the 
ISO/IEC 17024 standards “Conformity assessment – General 
requirements for bodies operating certification of persons”

CeRtified heAlthCARe  
teChnology MAnAgeR (ChtM)

In 2015, the AAMI Credentials Institute (ACI) initiated 
the Certified Healthcare Technology Manager (CHTM) 
program.8 ACI defines a CHTM as

“The healthcare technology manager is a person 
responsible for planning and directing activities of 
other healthcare technology management profes-
sionals, monitoring their work, and taking corrective 
actions when necessary. This HTM certification 
covers two major areas in healthcare technology 
management: the management of healthcare 
technology operations; and, the management of 
personnel. The functions of the manager are to 
include the participation in the “leadership” of the 
business enterprise. The manager is also expected 
to have the skills and understanding needed to 
perform strategic, business, and change manage-
ment as well as employee relation.”

This certification is not currently ANSI accredited.
Individuals interested in pursuing the CHTM designa-

tion must meet one of the following paths to be eligible 
for the program.

Path 1: A current certification as a clinical engineer (CCE), 
biomedical equipment technician (CBET), radiology 
equipment specialist (CRES), or a laboratory equipment 
specialist (CLES) with at least three (3) years of work 
experience as a supervisor or manager in the last five 
(5) years.
Path 2: Successful completion of the Department of 
Defense’s biomedical equipment maintenance techni-
cian (DOD BMET) training program with at least three 
years of work experience, military or civilian, as an HTM 
supervisor or manager in the last five years
Path 3: An Associate degree in biomedical technology, 
related health care discipline, information technology 
or business with at least three years of work experience 
as an HTM supervisor or manager in the last five years.
Path 4: A Bachelor’s degree or higher in biomedical 
technology, engineering, related health care discipline, 
information technology or business with at least two 
years as a manager within the last five years.



James O. Wear: Certification in the United States, Canada and Asia

17 J Global Clinical Engineering Special Issue 1: 15-22; 2018

Path 5: Work experience with or without a degree not 
related to biomedical technology, related health care 
discipline, information technology, or business manage-
ment. Seven years of work experience in the HTM field 
with three years of management experience in the last 
five years

In any of the paths, if the individual does not have 
the title of supervisor or manager, he/she would have to 
confirm that he/she performs management duties either 
through self or third-party attestation.

Recertification requirements for this certification are a 
combination of work experience and continuing education 
to demonstrate sustained competency and knowledge in 
the healthcare technology management field.

CeRtified in CliniCAl engineeRing (CCe)
Dr. Caesar Caceres, MD coined the term “Clinical Engi-

neer” in 1967 for engineers working with physicians in the 
clinical setting. At that time, various types of engineers, 
physical scientists, and physiologists were performing 
engineering type work in the clinical setting in hospitals. 
As more medical instrumentation came into the hospi-
tal, more of this type of personnel came into the field as 
well. Also, as BMETs were hired to maintain the medical 
instrumentation, engineers and physical scientists were 
hired to manage clinical/biomedical engineering depart-
ments in hospitals.

AAMI thought that engineers should be certified in 
clinical engineering since there were no academic pro-
grams that trained clinical engineers. Some of the major 
people working in the field of clinical engineering were 
not engineers but held degrees in some other scientific 
field. It was decided that a program should be developed 
to certify people in the clinical engineering field and not 
as clinical engineers. An initial Board of Examiners was 
established with prominent people in the clinical engi-
neering field. It was decided that for one year, individuals 
working in clinical engineering could be certified based 
on credentials. They had to have at least a BS degree in 
engineering or a physical science and at least three years 
experience working in the field of clinical engineering. These 
credentials were evaluated by the Board of Examiners. 
The AAMI certification program for clinical engineering 

was established in 1975 and within a year about 200 
individuals were certified in clinical engineering (CCE). 
After this first group of CCEs, the Board of Examiner de-
veloped a written exam and an oral exam to test future 
individuals for certification.

At this same time, another group of prominent individu-
als in the field decided that certification on credentials was 
the wrong approach to certifying people. They decided 
that people should take an exam to become certified in 
clinical engineering. As a result, five people self-certified 
themselves and developed an exam for certification in 
clinical engineering. This group became the American 
Board of Clinical Engineering (ABCE) and also started 
their certification program in 1975. Most of the initial indi-
viduals in this program were academic clinical engineers.

AAMI and the ABCE continued to certify individuals in 
clinical engineering until 1984. In 1983 the two groups 
began discussions on a possible merger of their programs. 
The merger was finalized in 1984 with all the ABCE CCEs 
being accepted into the AAMI certification program. As 
part of the merger the International Certification Commis-
sion for Clinical Engineering and Biomedical Technology 
(ICC) was established. Fifty individuals had been certified 
by the ABCE.

In 1979, AAMI started requiring CCEs to renew their 
certification every three years by demonstrating continuing 
education. In 1992, the renewal policy was that anyone 
certified after 1992 and not renewed would have their 
certification revoked. Anyone certified before 1992 that 
did not renew would become delisted. As of 2002, there 
were about 100 listed CCEs on the AAMI website. In 1999 
AAMI discontinued accepting applications for certification 
because there were not enough applicants to support the 
program financially. However, they did continue to ac-
cept renewals. At the time AAMI discontinued accepting 
applications for certification, 474 had become a CCE by 
credentials or exam including 50 certified by the Canadian 
Board of Examiners for Clinical Engineering. This also 
included several individuals in other countries certified 
by the US Board of Examiners. However only about 200 
had kept their renewal up-to-date.

In 2002, the Healthcare Technology Certification 
Commission (HTCC) was created under the Healthcare 



James O. Wear: Certification in the United States, Canada and Asia

J Global Clinical Engineering Special Issue 1: 15-22; 2018 18

Technology Foundation (HTF) to reestablish a CCE pro-
gram. A US Board of Examiners was created to develop a 
written and oral exam. The written exam was based on 
the American College of Clinical Engineering (ACCE) Body 
of Knowledge (BOK) determined by an ACCE survey of 
practicing clinical engineers. This survey asked the clinical 
engineers about the work that they were doing and the 
knowledge requirements. The new certification program 
accepted anyone from a previous certification program 
who demonstrated that they were current in the field by 
continuing education for a one-year period. There were 
112 individuals that were accepted in the new program 
from the previous program. The first exam was given in 
2004 with three individuals taking the exam.

In 2013 the HTCC begin looking for a new sponsoring 
body since new US tax policies were such that a non-profit 
foundation such as HTF could not have an income producing 
unit like the HTCC. They looked at various organizations 
as sponsors as well as considering becoming a stand-alone 
organization without a sponsor. Finally, AAMI and ACCE 
indicated an interest in becoming a sponsor and each 
presented their proposal. The ACCE was accepted as a 
sponsor since they guaranteed the exam process could 
continue to have the oral exam. AAMI was not sure they 
could continue to sponsor with the oral exam since they 
were trying to obtain ANSI recognition of their exam 
program. Thus, ACCE became the administrative sponsor 
for HTCC in 2014. At that time there were a little over 
200 individuals certified by the HTCC from the US and 
the Canadian Board of Examiners.

Individuals must meet the following qualifications to 
take the CCE exam:

• Three years of clinical engineering experience 
plus  

• Profession Engineer License or
• MS Eng or
• BS Eng plus 4 years total engineering experience or
• BSET in engineering technology plus 8 years total 

engineering experience.

They also must provide three professional references. 
The written exam is 150 multiple choice questions admin-
istered by a professional testing company. The questions 

are developed by the Board of Examiners and are based 
on the BOK developed by the ACCE. The oral exam is 
about 2 hours and given by two members of the Board of 
Examiners and is based on practical knowledge needed 
to function on the job.

CAnAdA CeRtifiCAtion
Canada uses the ICC for certifying BMETs and they 

add the requirement that an individual must have a BS 
in biomedical technology to take the exam.9 The exam is 
developed by the Canadian Board of Examiners under 
the ICC

Under the laws of the Canadian provinces and terri-
tories, the use of the title “engineer” in a job description 
requires that the incumbent be licensed as a professional 
engineer in that jurisdiction. Canada has always taken the 
position that to be eligible to seek certification in clinical 
engineering; an applicant must first obtain licensure as 
a professional engineer. Once a person is licensed as a 
professional engineer and is working in the field of clini-
cal engineering, then he or she can apply to the Canadian 
Board of Examiners for Clinical Engineering Certification.

By 1980, it was recognized that engineers working 
in the clinical engineering role required a distinct but 
unrecognized BOK to perform their tasks competently. 
Since there was no licensing process in place specifically 
for clinical engineering, leaders in Canada decided to 
establish a certification process that would be adminis-
tered by competent members of the profession. In order 
to begin such an effort, discussions were held with col-
leagues in the United States who had undertaken a similar 
approach under the leadership of the (AAMI). Canadians 
with established track records working in the profession 
were grandfathered as certified and established the first 
Canadian Board of Examiners for Clinical Engineering 
Certification. They developed a written exam and an 
oral exam.

This process of certification continued for several 
years. However, the initial rush of applicants dwindled, 
and it remained a voluntary activity with limited visibility 
amongst the health care community. By the late 1990s, 
the work of the Board had effectively ceased with very 
few applicants coming forward.



James O. Wear: Certification in the United States, Canada and Asia

19 J Global Clinical Engineering Special Issue 1: 15-22; 2018

Around 2008, there was a growing interest in certifi-
cation in Canada as younger engineers entered the pro-
fession and the need for skilled staff continued to grow. 
Members of the former Canadian Board were asked by 
the Canadian Medical and Biological Engineering Society 
(CMBES) to restart a Canadian certification process and 
bring it up-to-date. It was apparent that with the small 
number of certification applicants, it would be difficult to 
launch and sustain a self-supporting certification process. 
Since there are many similarities in the practice of clinical 
engineering between Canada and the United States, they 
decided to approach the US Board about the possibility of 
sharing aspects of the enhanced US exam process.

Adding further credibility to the process, The US Board 
of Examiners is accountable to the Health Technology 
Certification Commission, which oversees the work of 
the Board and ultimately decides on recommendations 
from the Board to certify individuals.

Discussions between the Canadian and US Boards 
went well with good support and encouragement from 
US colleagues. The main issue of divergence of practice 
between Canadian and US clinical engineers relates to 
the country specific codes, regulations and standards, 
an important but relatively small part of the written 
exam. In discussion, it was agreed that members of the 
Canadian Board would review the US written exam, to 
identify those questions requiring specific knowledge of 
US codes, standards and regulations. Out of a full exam 
of 150 multiple-choice questions, the total number of 
exempted questions is typically no more than 30. These 
questions are not counted for Canadian examinees and 
the same percentage pass mark is used. To compensate 
for the lack of written exam questions on Canadian codes, 
standards and regulations, it was decided to put an ad-
ditional (fourth) question into the Canadian oral exam 
process, specifically on these topics. The Canadian Board 
agreed to develop such a question using the same process 
as the US Board. In this way, Canadian candidates are 
examined through a slightly different but parallel process 
to their US counterparts.

It was agreed that Canadian applicants would register 
and be administered by the Secretariat to the US Board, 
to avoid setting up a parallel office in Canada. Sites are 
available in Canada to sit for the written exam, which is 

made available in both countries on a single date and time 
each year, early in November. All policies and procedures 
are harmonized, and the Canadian Board assists the US 
Board in the generation of new written and oral exam 
questions. Members of the two Boards discuss their 
work on a regular basis, and the Chairs of each Board sit 
on the HTCC.

The harmonized process was established in 2010 and 
remains in place. There has been good communication 
between each Board, and a generally high level of support 
for this harmonized process.

CoMMiSSion foR the AdvAnCeMent  
of heAlthCARe teChnology  

MAnAgeMent in ASiA (CAhtMA)
CAHTMA was initiated in 2005 with the endorsement 

of the Asian Hospital Federation.10 The Asian Hospital 
Federation (AHF) is an international non-governmental 
organization, supported by members from 14 countries 
in the Asia Pacific Region. CAHTMA is a member of the 
International Federation of Medical and Biological Engi-
neering (IFMBE) and initially had WHO advisers. It was 
established to provide a platform for health care profes-
sionals to discuss and exchange ideas on health care 
technologies and practices. Central to these objectives are 
the promotion of best technology management practices, 
the certification of clinical engineering practitioners and 
healthcare professionals and the dissemination of appropri-
ate management tools through seminars and workshops.

CAHTMA has certified a few clinical practitioners, but 
there has been no major need for certification in Malaysia 
since it has not been required. When CAHTMA started 
certification, the government was planning legislation to 
require certification for maintenance of medical equip-
ment. Technicians are certified as a level one clinical prac-
titioner with a written exam and experience which is like 
the ICC BMET. Engineers are certified as level two clinical 
practitioners with a written exam and an oral exam and 
experience which is similar to the HTCC CCE. In order to 
encourage more engineers to become certified, CAHTMA 
is going to use the process of certifying individuals based 
on credentials similar to what has been with the initial 
program in the US and Taiwan.



James O. Wear: Certification in the United States, Canada and Asia

J Global Clinical Engineering Special Issue 1: 15-22; 2018 20

CAHTMA is also certifying faculty for biomedical 
engineering technology programs which are developing 
with the increased need for technologist to maintain the 
medical equipment. The government is looking at requir-
ing these technologists to be certified for certain work. 
In 2012, lecturers at one school were tested as assessors 
and certified by CATHMA with Certification for Clinical 
Engineering Assessors. Lecturers who completed five 
weeks of training and passed the exams were certified 
by CATHMA with Certification for Clinical Engineering 
Trainers.

CeRtifiCAtion in tAiwAn
Certification in clinical engineering in Taiwan is per-

formed by the Taiwan Society for Biomedical Engineering 
(TSBME).11 In 2000, TSBME established the Certification 
Executive Committee for CE certification. During 2001, 
they certified clinical engineers by application. In 2003, 
they initiated a recertification program for CCE. The first 
testing for certification of clinical engineering and tech-
nologists of medical equipment was in 2007.

The TSBME provides certification for clinical engi-
neers, medical equipment technicians and biomedical 
engineers. In 2010 they had certified 93 clinical engineers, 
132 medical equipment technicians and 224 biomedical 
engineers. The clinical engineers and medical equipment 
technicians are for working in the hospitals and the bio-
medical engineers are for working in the medical device 
industry. This is the only certification that has separate 
certification for hospital and industry engineers.

To become certified an individual must be a member 
of TSBME. The requirements to take the certification 
exam are as follows:

• Clinical Engineer: MS degree in biomedical or 
related field plus at least one year of CE experience 
plus working in a hospital for more than 10 years.

• Medical Equipment Technician: BS degree in 
biomedical or related field plus at least one year of 
CE experience plus working in a hospital for more 
than 4 years.

• Biomedical Engineer: BS degree in Engineering plus 
at least two years of BME experience plus working 
in BME field for more than 4 years.

The content of the assessment exams by the TSBME 
for each of their certifications is as follows:

Clinical Engineer (core exam plus oral exam)
• Anatomy (24%)
• Medical Instrumentation (16%)
• Clinical Engineering (16%)
• Medical Imaging System (16%)
• Major Area: (Biomechanical or Biomaterial or Medical 

Electronics or Medical Information (28%)

Medical Equipment Technician (core exam)
• Anatomy (20%)
• Electronics & Electrical Safety (40%)
• Medical Instrumentation (40%)

Biomedical Engineer (core exam)
• Anatomy (20%)
• Medical Devices, Safety Regulation & GMP (10%)
• Major/Minor (Biomechanics plus Biomaterial or 

Medical Electronics plus Medical Instrumentation) 
Major 45% and Minor 25% (70%)

CeRtifiCAtion in JApAn
Clinical engineering in Japan is different from other 

parts of the world.12,13 It is the only country that the 
government certifies clinical engineering technologists 
(CETs). The CETs must graduate from a clinical engi-
neering training school which can be a university, junior 
college or training school and pass a national exam to be 
certified. The CETs are also called clinical engineers. The 
CETs are paramedical staff and specialize in the medical 
equipment essentials in medical care. About 35% work 
in hemodialysis and about 20% in maintenance. Others 
work in respiratory, operating room, ICU, heart related, 
hyperbaric and other areas.

The clinical engineer system was established in 1987 
by the Clinical Engineers Act. This act created the CET 
as a professional medical position responsible for the 
operation and maintenance of life-support systems under 
the direction of doctors. This act established a national 
qualification including passage of the 180-question exam 
in medicine, engineering and medical technology. In 2010 
there were about 28,000 certified CETs and about 18,000 



James O. Wear: Certification in the United States, Canada and Asia

21 J Global Clinical Engineering Special Issue 1: 15-22; 2018

current working in the field. The certification of the CETs 
is most equivalent to the CBET in the ICC system in the US.

In addition to the CET certification by the government, 
the Japan Society for Medical and Biological Engineering 
(JSMBE) has a Biomedical Engineering Certificate program.14 
The JSMBE has two classes of certification for biomedical 
engineers. The 1st class certification is for experienced 
clinical engineers and in 2008 the pass rate was 22.2% for 
433 applicants. The 1st class exam covers basic aspects on 
medical engineering and medical device related subjects. 
The 2nd class exam is for students or recent graduates of 
clinical engineering and many take it as preparation for 
the national CET exam. In 2008 the pass rate on the 2nd 
class exam was 29.3% for 1398 applicants.

CeRtifiCAtion in ChinA
In 2005, the international clinical engineer certifica-

tion was introduced in China.15 The Medical Engineering 
Division of the Chinese Medical Association hosted the 
first international clinical engineering certification train-
ing courses and certification examination. From 2005 to 
2016, eight sessions of lectures by international senior 
specialists and exams were done. A written exam based 
on the ACCE BOK with some adjustment for the practice 
of clinical engineering in China. The written exam is in 
English and is prepared by international senior specialists. 
Individuals that pass this 100-question multiple choice 
exam have to pass an oral exam in English to become cer-
tified. The oral exam is given by the international senior 
specialists. In the eight training sessions, there have been 
700 clinical engineering personnel from hospitals and 
universities. There have been 219 individuals that have 
passed the two exams and been certified as international 
clinical engineers.

In the past 7 years, China has been working to estab-
lish its own certification program. In 2012, the Medical 
Engineering Division of the Chinese Medical Association 
carried out Chinese Registered Clinical Engineer Certifi-
cation (RCEC) training and examination. The candidates 
were junior engineers in large hospitals or new gradu-
ates with majors in medical engineering. This exam is the 
basic admission exam to the occupational qualification 
of clinical engineering.

The RCEC exam consists of a theoretical exam and 
practical test. There is a Chinese exam question bank from 
which the theoretical questions are randomly selected. 
Candidates then take a practical test including repair, 
measurement and maintenance of medical devices. A 
committee of Chinese clinical engineering experts evalu-
ates the ability of the candidates and determines if they 
are qualified to receive the RCEC. In 2012, there were 
176 people who took the exam and 56 passed to become 
certified as RCEC.

In the future, the candidates for International Clinical 
Engineering Certification will be mostly senior clinical 
engineers with more than 10 years experience.

They are establishing a continuing education for both 
certification to maintain and improve the quality of the 
clinical engineers. The Medical Engineering Division plans 
to recommend to the government to officially authorize 
clinical engineer training and certification.

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