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Please visit: www.beam.org.my
To:
All BMET (Biomedical Equipment Technician)
Date: 10th
December 2014
Sir,
Re: BEAM Technical Training: BMET COMPETENCY TRAINING AND CERTIFICATION On
Electrical Safety Testing( EST) for Medical Electrical Equipment with IEC 62353
Compliance .
Biomedical Equipment Technician (Bmet) is one of several professional disciplines
contributing to safe, effective and economical health care. The role and primary
responsibility of a Bmet services are maintaining of medical device technologies,
including adherence to recognized safety, accuracy and efficiency standards.
The main objective of this training is to understand the principle of the IEC 62353 testing,
with the benefits of preparing one to become a competent BMET personnel in fulfilling
industries standards in line with the MDA (737) Malaysian Medical Device Act.
Please refer to the pamphlets attached for more details.
Yours sincerely
Khairul Azmy Kamaluddin
Vice President
Please visit: www.beam.org.my
BIOMEDICAL COMPETENCY
TRAINING AND EXAMINATION
On Electrical Safety Testing for Medical Electrical Equipment
with IEC 62353 Compliance
Venue : Wisma BEAM
Date : 10th MARCH 2015
Time : 9:30 AM
Fee : RM 1,300.00 Non-Member
: RM 800.00 BEAM Member
Closing Date : 3rd March 2015
Eligibility:
1) Passed the IEC60601-1 examination conducted by BMETIC
(BMET International Certification)
In this training you will gain:
 The important of Electrical Safety
Test.
 Differentiation between the IEC
62353 and IEC60601-1
 Learn how to identify the error
(leakage current)
 Develop EST check list
Benefits of this training:
 Important to fulfill the standard of
industries
 Get to know the alternative EST test
technique
 Be a competence biomedical
personnel with IEC 62353
 Fulfilled the need of MDA (737)
and MS2058:2009
Competency Examination
Examination structure:
 30 multiple choice and 10
written answer examination
 Passing mark: 80% and above
Examination:
I. Terminology
II. Parameters
III. Circuits
IV. Safety Standard Limits
V. Principle
VI. Alternative Test Technique
Competency Certificate and Badge will be given for those
who passed the examination
Limited to 20
Candidates per
session
Please visit: www.beam.org.my
The Trainer
Nik Zaidi Nik Bulyamin is the founder of NIQ Engineering Sdn Bhd.
He also well verse in biomedical testing equipment with 18 years’
experience in the field. Factory trained personnel for Dynatech
Nevada Inc, Clinical Dynamics Corporation and Michigan
Instrument Incorporation in USA. Beside manage his own business
he also conducted his own training such Familiarization of
Biomedical Test Equipment and Electrical Safety Test Training the
training included national and international. His completion project
that has done is the Biomedical Calibration Laboratory for Sri
Comm Instruments Sdn Bhd, complete setup for Biomedical
Calibration Lab for NIQ Engineering Sdn. Bhd. He also certified
trainer from HRDF (human resource department fund).
Please visit: www.beam.org.my
Application Form – IEC 62353
BIOMEDICAL COMPETENCY TRAINING AND CERTIFICATION
On Electrical Safety Testing for Medical Electrical Equipment with IEC 62353 Compliance
Venue : Wisma BEAM, Kota Warisan
Month : 10th MARCH 2015
Time : 9:30 AM
Closing Date: 3rd March 2015
Personal information:
Name: NRIC number:
Age: House Tel:
Mobile number: Designation:
Company name: Email:
Company address: Office Tel:
Experience(Years) in Biomedical: University/College/institute/School:
Highest Education level: BEAM Membership No (If Applicable):
I hereby declare that, to the best of my knowledge and belief, the particular given above and the
declaration made therein are true.
(_____________________________)
Name:
Date:
Company Stamp (if applicable):
Please fax the completed form to: 03-7846744 (Your application will be process within a week for
approval) For inquiry please contact: 019-2370802 (Pn. Fairoz) or email to beamtraining@gmail.com
Please visit: www.beam.org.my
LAWS OF MALAYSIA (Act 737) :MEDICAL DEVICE ACT 2012
Chapter 4
General Duty
Usage, operation, maintenance, etc., of medical device
43. (2) A person-
(a) using or operating a medical device on third party; or
(b) installing, testing, commissioning, maintaining and disposing of a medical device,
shall have the qualification and competency as prescribed by the Minister.
(6) Any person who contravenes subsection (1) or (2) commits an offence and shall, or conviction, be
liable to fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding
one years or to both.
MS 2058: 2009 Code Of Practice For Good Engineering Maintenance Management Of Active Medical
Devices (First Revision)
Biomedical Engineering is one of several professional disciplines contributing to safe, effective and
economical health care. The role and primary responsibility of a Biomedical Engineering services are
management of medical device technologies, including adherence to recognized safety, quality, cost, and
efficiency standards. Biomedical Engineering is a learned profession that combines expertise and
responsibilities in engineering, science, technology, and medicine. Since public health and welfare are
paramount considerations in each of these areas, Biomedical Engineers shall uphold an appropriate level
of competencies embodied in its professional practice, research, patient care, and training. The level of
competencies shall reflect the standards of professional and personal practice for Biomedical Engineers.

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62353 MARCH 2015

  • 1. Please visit: www.beam.org.my To: All BMET (Biomedical Equipment Technician) Date: 10th December 2014 Sir, Re: BEAM Technical Training: BMET COMPETENCY TRAINING AND CERTIFICATION On Electrical Safety Testing( EST) for Medical Electrical Equipment with IEC 62353 Compliance . Biomedical Equipment Technician (Bmet) is one of several professional disciplines contributing to safe, effective and economical health care. The role and primary responsibility of a Bmet services are maintaining of medical device technologies, including adherence to recognized safety, accuracy and efficiency standards. The main objective of this training is to understand the principle of the IEC 62353 testing, with the benefits of preparing one to become a competent BMET personnel in fulfilling industries standards in line with the MDA (737) Malaysian Medical Device Act. Please refer to the pamphlets attached for more details. Yours sincerely Khairul Azmy Kamaluddin Vice President
  • 2. Please visit: www.beam.org.my BIOMEDICAL COMPETENCY TRAINING AND EXAMINATION On Electrical Safety Testing for Medical Electrical Equipment with IEC 62353 Compliance Venue : Wisma BEAM Date : 10th MARCH 2015 Time : 9:30 AM Fee : RM 1,300.00 Non-Member : RM 800.00 BEAM Member Closing Date : 3rd March 2015 Eligibility: 1) Passed the IEC60601-1 examination conducted by BMETIC (BMET International Certification) In this training you will gain:  The important of Electrical Safety Test.  Differentiation between the IEC 62353 and IEC60601-1  Learn how to identify the error (leakage current)  Develop EST check list Benefits of this training:  Important to fulfill the standard of industries  Get to know the alternative EST test technique  Be a competence biomedical personnel with IEC 62353  Fulfilled the need of MDA (737) and MS2058:2009 Competency Examination Examination structure:  30 multiple choice and 10 written answer examination  Passing mark: 80% and above Examination: I. Terminology II. Parameters III. Circuits IV. Safety Standard Limits V. Principle VI. Alternative Test Technique Competency Certificate and Badge will be given for those who passed the examination Limited to 20 Candidates per session
  • 3. Please visit: www.beam.org.my The Trainer Nik Zaidi Nik Bulyamin is the founder of NIQ Engineering Sdn Bhd. He also well verse in biomedical testing equipment with 18 years’ experience in the field. Factory trained personnel for Dynatech Nevada Inc, Clinical Dynamics Corporation and Michigan Instrument Incorporation in USA. Beside manage his own business he also conducted his own training such Familiarization of Biomedical Test Equipment and Electrical Safety Test Training the training included national and international. His completion project that has done is the Biomedical Calibration Laboratory for Sri Comm Instruments Sdn Bhd, complete setup for Biomedical Calibration Lab for NIQ Engineering Sdn. Bhd. He also certified trainer from HRDF (human resource department fund).
  • 4. Please visit: www.beam.org.my Application Form – IEC 62353 BIOMEDICAL COMPETENCY TRAINING AND CERTIFICATION On Electrical Safety Testing for Medical Electrical Equipment with IEC 62353 Compliance Venue : Wisma BEAM, Kota Warisan Month : 10th MARCH 2015 Time : 9:30 AM Closing Date: 3rd March 2015 Personal information: Name: NRIC number: Age: House Tel: Mobile number: Designation: Company name: Email: Company address: Office Tel: Experience(Years) in Biomedical: University/College/institute/School: Highest Education level: BEAM Membership No (If Applicable): I hereby declare that, to the best of my knowledge and belief, the particular given above and the declaration made therein are true. (_____________________________) Name: Date: Company Stamp (if applicable): Please fax the completed form to: 03-7846744 (Your application will be process within a week for approval) For inquiry please contact: 019-2370802 (Pn. Fairoz) or email to beamtraining@gmail.com
  • 5. Please visit: www.beam.org.my LAWS OF MALAYSIA (Act 737) :MEDICAL DEVICE ACT 2012 Chapter 4 General Duty Usage, operation, maintenance, etc., of medical device 43. (2) A person- (a) using or operating a medical device on third party; or (b) installing, testing, commissioning, maintaining and disposing of a medical device, shall have the qualification and competency as prescribed by the Minister. (6) Any person who contravenes subsection (1) or (2) commits an offence and shall, or conviction, be liable to fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one years or to both. MS 2058: 2009 Code Of Practice For Good Engineering Maintenance Management Of Active Medical Devices (First Revision) Biomedical Engineering is one of several professional disciplines contributing to safe, effective and economical health care. The role and primary responsibility of a Biomedical Engineering services are management of medical device technologies, including adherence to recognized safety, quality, cost, and efficiency standards. Biomedical Engineering is a learned profession that combines expertise and responsibilities in engineering, science, technology, and medicine. Since public health and welfare are paramount considerations in each of these areas, Biomedical Engineers shall uphold an appropriate level of competencies embodied in its professional practice, research, patient care, and training. The level of competencies shall reflect the standards of professional and personal practice for Biomedical Engineers.