CERTIFICATION HANDBOOK (CHB001) - ACCB Certification |

CERTIFICATION HANDBOOK CHB001

@COPYRIGHT_ACCB-Private and Confidential Page | 1

CERTIFICATION HANDBOOK

(CHB001)

Revision 2.0, 18th July 2018

ACCB CERTIFICATION SDN BHD

1-17 PERDANA THE PLACE, JALAN PJU 8/5G, BANDAR DAMANSARA PERDANA,

47820 PETALING JAYA, SELANGOR, MALAYSIA

TEL/FAX: +60 3-7732 6056

EMAIL: [email protected]



CONTENTS

NO ITEM PAGE

1 Introduction of ACCB Certification 4

2 Impartiality 4

3

Policy and Objective

3.1 Policy

3.2 Quality Objective

4

4 Definition of Certified Person 5

5

Code of conduct

5.1 ACCB Code of Conduct

5.2 Applicants/Candidates/Certified Person Right

5.3 Applicants/Candidates/Certified Person Duties

5.4 Examination Policy

5.5 Examination Rules & Regulations

5.6 Certification Certificate, Mark and the Rules Governing Its Use

5.7 Definition in Regulation

5.8 Use of The Certification Mark

5.9 Use of The Certification Certificate

5.10 Penalties and Appeal

5.11 Confidentiality

5.12 Changes to The Legislation

5.13 Changes to The Regulation Governing the Use of The Mark

5.14 Technical Details

5

5

6

6

7

7

8

8

9

9

9

9

10

10

10

6 Pre-requisite Requirement 11

7

Certification Scheme

7.1 Certification Scope for Level 1


7.3 Certification Scope for Electrical Safety Testing (IEC 60601, IEC

62353 & IEC 61010)

14

14

15

16

8 Fees & Refund 17

9

Certification Process Flow

9.1 Application Process

9.2 Eligibility Appeals

9.3 Examination Preparation

9.4 Security

9.5 Scoring and Results

9.6 Change of Contact Information

9.7 Use of Certification Marks and Designations

9.8 Maintaining Your Certification

17

18

18

18

21

21

21

22

22



NO ITEM PAGE

10

Recertification Process Flow

11.1 Recertification

11.2 Recertification Procedures

23

24

25

11

Complaint Process Flow

11.1 Complaints Related to Certification Process

11.2 Complainant

25

26

27

12

Special Arrangement

12.1 Request special arrangement

12.2 Request on site examination

27

27

27

13

Appeal Process

13.1 Type of Appeal

13.2 Appeals Body

13.3 Scheme Committee Consideration of the Appeal

28

28

28

14 Confidentiality 28

15

Examination

15.1 BEM-BDIA01 – APPENDIX 1

15.2 BEM-BTHE01 – APPENDIX 2

15.3 BEM-BLAB01 – APPENDIX 3

15.4 BEM-ITHDU02 – APPENDIX 4

15.5 BEM-ITVEN02 – APPENDIX 5

15.6 BEM-OEST03 – APPENDIX 6

29

32

37

40

42

44



1. Introduction of ACCB Certification Sdn Bhd

ACCB Certification Sdn Bhd is the first Accredited Certification Body in Malaysia to certify

competent person for Biomedical Engineering Maintenance Services Personnel.

ACCB has attained accreditation for ISO/IEC 17024:2012 Conformity Assessment-General

Requirements for Bodies Operating of Persons from Department of Standard Malaysia (DSM)

based on MS2058:2009 Code of Practice for Good Engineering Maintenance Management of

Active Medical Device.

ACCB has been accredited by DSM on 5th June 2017.

2. Impartiality

ACCB understand the importance of impartiality in carrying out its certification activities,

manages conflict of interest and ensures the objectivity of its certification activities. ACCB has

established and maintain the Management of Impartiality Procedure (CQP010) to avoid any

impartiality matters.

3. Policy & Quality Objective

3.1 Policy

ACCB is committed in producing quality Certified Person for required certification to all

customers in accordance to our approved procedures. ACCB is committed to ensure:

a) All personnel avoid any involvement in any activities that would diminish confidence

in its competence, impartiality, judgment or operational integrity of the certification.

b) Management and all personnel are free from any undue internal and external

commercial, financial and other pressures and influences that may adversely affect the

quality of their assessments or certifications.

c) Provide up-to-date examination materials and in a timely manner, using input from

our expertise and other interested parties.

d) Apply determined transparent process which allows constant performance verification

to the benefit of our customers.

e) Compliance with the requirement of ISO/IEC 17024:2012 – (Conformity Assessment-

General requirements for bodies operating certification of persons).

f) Implements continuous improvement in the field of customer’s relationship and

market needed

Our Quality Policy Statement shall be reviewed during the Management Review Meeting

and is issued under the authority of Top Management.

We regard competence and responsibility of staff and others parties as one of the main

aspects for our participants’ and customers’ satisfaction. This is main component for the

high quality of our services and our business success.



3.2 Quality Objective

a) To produce 100 Certified Persons in five (5) years

b) To achieve 80% customer satisfaction

c) To comply 100% of legal and other requirements

d) To achieve zero complaint from other parties

4. Definition of Certified Person

Certified Person is a person who have a competence as per prescribed according to Clause 3.7,

in MS2058:2009, competence is a standardised requirement for an individual to properly

perform a specific job. It encompasses a combination of knowledge, skills and behaviour

utilised to improve performance. More generally, competence is the state or quality of being

adequately or well qualified, having the ability to perform a specific job/role.

5. Code of Conduct

The Code is designed to provide both appropriate ethical practice guidelines and enforceable

standards of conduct for all ACCB applicants, candidates, and certified persons. The Code also

serves as a professional resource for healthcare technology practitioners, as well as for those

served by ACCB candidates and certified persons in the case of a possible ethical violation.

5.1 ACCB Code of Conduct

All ACCB applicants, candidates, and certified persons must agree to comply with the

ACCB Code of Conduct as outlined below:

a) I will conduct my professional activities with honesty and integrity.

b) I will uphold my professional conduct to the highest ethical standards.

c) I will represent my certifications and qualifications honestly and provide only those

services for which I am qualified to perform.

d) I will maintain and improve my professional knowledge and competence through

regular self-assessments, continuing practice, continuing education or training.

e) I will act in a manner free of bias and discrimination against clients, colleagues, or

customers.

f) I will maintain the privacy of individuals and confidentiality of information obtained

in the course of my duties unless disclosure is required by legal authority.

g) I will obey all applicable laws, regulations, and codes.

h) I will follow all certification policies, procedures, guidelines, and requirements of the

ACCB.



5.2 Applicant/Candidate/Certified Person Rights

a) The candidate has the right to ask for reschedule of the examination by informing

ACCB at minimum of five (5) working days prior the examination day.

b) All information supplied by the applicants, candidates or Certified Person and

information obtained during the certification process are not disclosed to an

unauthorized party without the written consent of the individual (applicant, candidates

or Certified Person), except where the law requires ACCB to release the confidential

information, the applicant, candidate or Certified Person will be notified as to what

information will be provided.

c) All Certified Person will receive a certificate and ID card upon certification.

d) All applicants, candidates or Certified Person have right to raise an appeal against to

the certification decisions by sending email to [email protected] including all

details of their appeal.

e) All the applicants, candidates or Certified Person have right to raise a complaint in

case of any dissatisfaction by sending email to [email protected] including all

details of their complaints.

f) Applicant with special needs may request for accommodation by sending email to

[email protected] including all details of their special needs.

5.3 Applicant/Candidate/Certified Person Duties:

a) All applicant must comply with the relevant provision of the certification

requirements and to supply any information needed for the assessment.

b) All applicant must provide genuine and valid information and details in the

application form as they will used to assess his competency for granting the

certification.

c) All candidates must notify ACCB in case if the examiner is known to him prior to the

examination process to prevent any conflict of interest.

d) All candidates must comply with ACCB Examination Policy, Rules and Regulations

(5.4) in order to maintain the integrity and security of the examination process and

not to release any confidential examination materials or participating in fraudulent

test-taking practices. An irregular or improper behaviour during examination that is

observed or uncovered by other means will be considered a subversion of the

certification of the certification process and will initiate grounds for invalidation of

the candidate's examination.

e) All Certified Person must not use the certification in such a manner as to bring ACCB

into disrepute and not to make any statement regarding the certification which the

certification body considers misleading or unauthorized.

f) All Certified Person can make claims regarding certification only with respect to the

scope for which the certification has been granted.

g) All Certified Person must be notified by ACCB in written to discontinue the use of

all claims to certification that contain any reference to the certification body or

certification upon suspension or withdrawal of certification, and to return the

certificates issued by ACCB.

h) All Certified Person must inform the ACCB, without delay, of matters that can affect

his capability to fulfil the certification requirements by sending email to

[email protected] including all details information.

mailto:[email protected]






5.4 Examination Policy

ACCB had established a policy to ensure security of throughout the examination material

and certification process which is:

“All personnel need to protect the secure and the confidentiality of examination

materials and certification process from being stolen or seen by non-authorized

people”

5.5 Examination Rules and Regulations

a) Examination candidates should attend each examination at least thirty (30) minutes

before the designated starting time.

b) Instructions from the Examination Invigilator must be carried out promptly.

c) No book, bag/handbag, notes, or other unauthorised material may be brought into the

Examination Room without the prior approval of the Invigilator.

d) Candidates must ensure that there is no writing on any rulers, set-squares, calculators

and other such instruments brought into the Examination Room.

e) Communication with another candidate is not permitted. If an examination, candidate

requires assistance; he/she should attract the attention of the Invigilator, taking care

not to disturb other candidates.

f) Any behaviour or activity which causes inconvenience or disruption to other

examination candidates is not permitted. Please avail of the toilets before entering the

Examination Room.

g) Mobile phones, electronic devices (with the exception of standard pocket calculators

falling within the definition of 12 below) or mobile communication devices are not

permitted in the examination room.

h) Candidates

will not be permitted to enter the Examination Room after thirty (30) minutes of

examination time has started;

will not be permitted to leave the Examination Room during the last thirty (30)

minutes of the Examination and;

at the end of examination candidates must remain seated until their examination

material has been collected by the Invigilator and until they are permitted to do

so.

i) Application fee will not be refunded if the candidate fails to attend the examination

as per schedule. However, they may reschedule the date by notifying ACCB within 5

workings days from the scheduled examination date.

j) A candidate must under no circumstances leave his/her seat unless permitted to do so

by the Invigilator. A candidate wishing to leave his/her seat should raise his/her hand

to attract the Invigilator’s attention.

k) All examination material must be handed up to an Invigilator after the candidate has

finished his/her examination.

l) No candidate shall take out of the Examination Room any answer book(s) or part of

an answer book, whether used or unused or other supplied material.

m) For the purposes of identification and registration during examinations, all candidates

are required to present the slip examination and identity card.



n) Where an open book examination is scheduled all parties must be informed, prior to

the examination, of the material permissible in the Examination Room. Any such

material may be examined by the Invigilator or any such other person(s) authorised

by ACCB.

o) Any complaint concerning the examinations should be brought to the attention of the

Invigilator immediately. The Invigilator will inform the ACCB personnel of the

complaint. All candidates are deemed to have read and to have agreed to abide by

these and other examination regulations as determined by the ACCB from time to

time.

p) Any infringement or violation of these regulations may have serious consequences

and may be withdraw from the examination.

q) It is in the interests of all examination candidates to co-operate to ensure that the

examinations are conducted in a proper and orderly manner.

5.6 Certification Certificate, Mark and the Rules Governing Its Use

These Regulations relate to the ACCB System Certification Mark (the “Certification

Mark”) as shown in the Appendix 1 owned by ACCB for the purposes hereof.

The Certification Mark should never be used by the Certified Person as is. ACCB will

provide the Personnel with the right logo to be used. ACCB reserves the right to replace

the Certification Mark as shown in the Appendix 1 by another certification mark at any

time.

Use of the Certification Mark for a renewable three-year period is strictly limited to the

Certified Person whose recertification has been successfully certified by ACCB.

5.7 Definition in Regulation

a) “Accreditation Body” means ACCB, the body that has accredited for certifying

competence of personnel of third parties.

b) “Accreditation Mark” means the Accreditation Body’s mark accredited to the

certified competence of personnel and has been successfully certified unless the

Accreditation Body does not permit its use.

c) “Certificate” means the certificate of conformity and assessment schedule issued by

the Certification Body specifying the scope of certification of the Certified Person.

d) “Certification Scheme number” means the number which is indicated in each

particular Standard.

e) “Certified Person” means the person to whom a Certificate is issued.

f) “Codes of Practice” means a technical document describing ACCB conditions under

which the Certificate and the Certification Mark may be delivered, renewed,

suspended or cancelled.

g) “Improper Use” of the Certification Mark means any use which infringes these

Regulations. It also means imitation, counterfeiting and dilution of the Certification

Mark.

h) “Use” means the lawful, authorized, restricted, non-exclusive, limited and revocable

right to use the Certification Mark.



5.8 Use of The Certification Mark

The Certified Person agrees that:

a) It will use the Certification Mark only in the manner prescribed herein and in the

Certificate.

b) It will use the Certification Mark only in relation to its scope of certification or

competence.

c) It will use the Certification Mark on a way as to create no confusion between

matters referred to in the scope of certification and other matters.

d) It will not use the Certification Mark or the Accreditation Mark on test reports or

certificates of compliance such as calibration certificates or certificates of

analysis.

Use of the Certification Mark does not exonerate the Certified Person from any liability

imposed by law regarding the performance of its services and the performance, design,

manufacturing, shipment, sale or distribution of its products.

5.9 Use of The Certification Certificate

The Certified Person agrees that:

a) To complies with the relevant provisions of the certification scheme

b) To makes claims regarding certification only with respect to the scope or which

certification has been granted

c) Not to use the certification in such a manner as to bring the ACCB into disrepute,

and not to make any statement regarding the certification which the ACCB

considers misleading or unauthorized.

d) To discontinues the use of all claims to certification that contain any reference to

the ACCB or certification upon suspension or withdrawal of certification and

returned any certificates issued by ACCB

e) Not to use the certificate in a misleading manner.

5.10 Penalties and Appeal

In case of improper use of the Certification mark, the ACCB may forthwith suspend or

withdraw the certification and the right to use the Certification Mark in accordance with

the sanctions procedures that will be provided by the ACCB upon request. The Certified

Person may appeal the ACCB’s decision in accordance with the appeal procedure that will

be provided by the ACCB upon request.

5.11 Confidentiality

Unless otherwise agreed by the ACCB, the Certified Person shall keep confidential all

documents received from the ACCB with the exception of the Certificate, these

Regulations and the Appendix thereof.



5.12 Changes to The Legislation

ACCB complies with all national and international laws, regulations and standards in force

concerning the right to use the Certification Mark or the conditions for obtaining said right.

It will give the Certified Person notification of the changes there to and the Personnel will

be obligated to apply all modifications resulting from said changes.

5.13 Changes to The Regulations Governing the Use of The Mark

ACCB reserves the right to modify these Regulations at any time. It will give the Certified

Person written notification of all changes there to and the Certified Person will be obligated

to apply said changes.

5.14 Technical Details

a) The Certification Mark shown in Appendix 1 is owned by ACCB and ACCB will

provide the Certified Person with the right logo to be used.

APPENDIX 1

b) On documents printed in more than one colour, the Colour Code is R:202 G:74 B:127

(#CA4A7F) as per attached colour code:-

c) The Certification Mark can be enlarged as well as reduced as long as the text remains

legible.



6. Pre-requisite Requirement

Prerequisites are the qualifications or competence required by a certification scheme for persons

before can be certified.

a) Have attended technical training related to the code of certification applied (from any

Training Provider).

b) Fulfil the qualification and experience as stipulated in MS2058 : Table A9 – Biomedical

Engineering Career Development Matrix



Table A9. Biomedical Engineering career development matrix

Qual1 Exp2 Cert3 Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert

1 Degree in Biomedical

Engineering√ 6 mth Passed A √ 1 year

Passed A

and B√ 3 years

Passed A, B and

Any of C1, C2, C3

or C4

√ 3 years

Passed Any of

C1, C2, C3 or C4

and D

√ 5 years

Passed A and/or B, C, D

with Relevant Mgmt 4

Cert

2 Degree in Electronic Engineering √ 9mth Passed A √ 2 year Passed A

and B√ 3 years

Passed A, B and

Any of C1, C2, C3

or C4

√ 3 years

Passed Any of

C1, C2, C3 or C4

and D

√ 5 years



Cert

3 Degree in other relevant

engineering√ 1 year Passed A √ 3 year

Passed A

and B√ 5 years

Passed A, B and

Any of C1, C2, C3

or C4

√ 3 years

Passed Any of

C1, C2, C3 or C4

and D

√ 5 years



Cert

4 Diploma in Biomedical

Engineering√ 1 year Passed A √ 5 year

Passed A

and B√ 7 years

Passed A, B and

Any of C1, C2, C3

or C4

√ 3 years

Passed Any of

C1, C2, C3 or C4

and D

√ 10 years



Cert

5 Diploma in Electronic

Engineering√ 1 year Passed A √ 5 year

Passed A

and B√ 7 years

Passed A, B and

Any of C1, C2, C3

or C4

√ 3 years

Passed Any of

C1, C2, C3 or C4

and D

√ 10 years



Cert

6 Diploma in other

relevant engineering

field

X 2 year Passed A X 5 year Passed A

and BX 7 years

Passed A, B and

Any of C1, C2, C3

or C4

X 10 years

Passed Any of

C1, C2, C3 or C4

and D

X 10 years



Cert

7 Certificate in Biomedical

EngineeringX 1 year Passed A X 7 year

Passed A

and B

8 Certificate in Electronic

EngineeringX 1 year Passed A X 7 year

Passed A

and B

9 Certificate in other relevant

engineering fieldX 2 year Passed A X 7 year

Passed A

and B

10 Lower qualifications X 2 year Passed A X 10 year Passed A

and B

1 This means “qualification”.2 This means “experience”.3 This means “certificate”.4 This means “management”.

Management

Biomedical maintenance competency levels

Entry levels Level 1 Level 2 Level 3 Equipment Specialist



Table A9. Biomedical Engineering career development matrix (concluded)

Certification

Category Biomedical Engineering maintenance competency certifications description

A Basic Biomedical Equipment Maintenance Certification. Provided by competent certifying body recognised by MOH. (Certificate

of Competency Biomedical Engineering Maintenance Level 1)

B Intermediate Biomedical Equipment Maintenance Certification. Provided by competent certifying body recognised by MOH.

(Certificate of Competency Biomedical Engineering Maintenance Level 2)

C1

Biomedical Equipment Specialisation Maintenance Certification in Radiology (Ionizing & Non-Ionizing) & Imaging medical

devices. Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering

Maintenance Level 3 - Radiology and Imaging)

C2 Biomedical Equipment Specialisation Maintenance Certification in Laboratory equipment and devices. Provided by competent

certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 3 - Laboratory)

C3 Biomedical Equipment Specialisation Maintenance Certification in Diagnostic medical devices. Provided by competent certifying

body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 3 -Diagnostics)

C4 Biomedical Equipment Specialisation Maintenance Certification in Therapeutic medical devices. Provided by competent certifying

body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 3 - Therapeutic)

D

Advanced Biomedical Equipment Specialisation Maintenance Certification in any specialisation of medical devices. Provided by

equipment manufacturer and endorsed by competent certifying body recognised by MOH. [Certificate of Competency Biomedical

Engineering Maintenance Level 4 (by Medical Device Model)]



7. Certification Scheme

Each certification requires a separate, complete application and a separate examination.

Exams are offered in English only.


No

Certification

Code

Certification Scope

Details

1 BEM-

BLAB01

Competency on Biomedical Engineering

Maintenance for Basic Active Medical Device

(Laboratory) Level 1

APPENDIX 1

2 BEM-

BDIA01



(Diagnostic) Level 1

APPENDIX 2

3 BEM-

BTHE01



(Therapeutic) Level 1

APPENDIX 3

The assessment strategy for these certifications are through the Examination in two (2)

hours in English with 100 multiple choice objective questions to evaluate the knowledge

and skill of the candidate. Candidate need to obtain correct answer for 70 questions to pass

the examination (70%).The examination weightage approximately are:

Examination Question Weightage *

a) Introduction of Basic Active Medical Device

b) Functions & Operations

c) Safety and Regulation

d) Service and Repair

e) Managing

Refer to Scheme Outline

100%

15%

30%

15%

30%

10%




No

Certification

Code

Certification Scope

Details

1 BEM-

ITHDU02


Maintenance for Intermediate Active Medical

Device (Therapeutic-Dialysis) Level 2

APPENDIX 4

2 BEM-

ITVEN02


Maintenance for Intermediate Active Medical

Device (Therapeutic-Ventilator) Level 2

APPENDIX 5

The assessment strategies for this certification is consist of Written Examination (WE)

with 100 objective questions and Oral Assessment (OA) to evaluate the knowledge and

skill of the candidate. Candidate shall attend both the Written Examination (WE) and Oral

Assessment (OA) with the passing marks is 70%. The percentage ratio of the Written

Examination (WE) to Oral Assessment (OA) is 70:30.

a) Written Examination (WE)

Examination is two (2) hours and it is a closed book exam consisting of 100 multiple choice

questions in English to evaluate the knowledge and skill of the candidate. Candidate need

to obtain correct answer for 70 questions to pass the examination (70%). The examination

weightage approximately are:

Examination Question Weightage *

a) Introduction of Intermediate Active Medical Device

b) Functions & Operations

c) Safety

d) Service and Repair

e) Managing

*Refer to Scheme Outline

100%

15%

25%

15%

30%

15%

b) Oral Assessment (OA)

Candidate will be given 30 minutes to study one scenario related to the certification scope.

Based on the scenario, candidate will have to answer 5 questions via interview session

conducted by examiner in 30 minutes.



7.3 Certification Scope for Electrical Safety Testing (IEC 60601, IEC 62353 &

IEC 61010)

No

Certification

Code

Certification Scope

Details

1 BEM-

OEST03


Maintenance for Electrical Safety Testing

(IEC 60601, IEC 62353 & IEC 61010)

APPENDIX 7

The assessment strategy is through the Examination in 1(one) hour in English,

with 50 multiple choice objective questions to evaluate the knowledge and skill

of the candidate. Candidate need to obtain correct answer for 35 questions to

pass the examination (70%). The examination weightage approximately is:

Examination Questions Weightage*

f) Objective of performing Electrical Safety Testing

g) Physiological Effects / Shock Hazards

h) Standards Requirements

i) Classification of Active Medical Equipment

j) Type of Applied Part in Medical Equipment

k) Limit and Parameters

l) Others

Refer to Scheme Outline

100%

10%

10%

14%

16%

16%

20%

14%



8. Fees & Refund

Applicants who ineligible for examination will be refunded 70% from application fees.

Candidates who failed the examination are not entitled for any refund of application fees.

9. Certification Process Flow

Start

Application

Certification

Examination

PASS

FAIL

Applicant need to submit: 1. Application for Certification/Recertification Form

Other supporting documents 2. Passport sized photograph 3. Copy of Identification Card/ Passport 4. Copy of Highest Education Certificate 5. Copy of Full Academic Transcript 6. Copy of Competency Training Certificate 7. Copy of Fee Payment Slip 8. Employment Confirmation Letter by Employer 9. Copy of Trainer Information such as CV / Training Brochure / etc

Notification & Assessment

NO

YES

ACCB to:-- Notify applicant on acknowledgement of application- Review application form and supporting document

ACCB to:-- issue certificate to Certified Person once received Acceptance of Agreement for Certified Persons Code of Conduct .

End

3 WORKING

DAYS

Applicant

ACCB

ACCB

ACCB &

Candidate

Successful

10 WORKING

DAYS

EXPLAINATIONPERSON

IN-CHARGE

Candidate to bring along:-- Examination Slip- Original IC / Passport

ACCB to:-- Notify applicant either successful / unsuccessful- Successful will be providesd examination slip- Update Certification Registry

7 WORKING

DAYS

Feedback

Candidate to:-- Give feedback on examination status at least on 5 working days before exam date.

20 WORKING

DAYS

Candidate

ACCB to:-- notify candidate on examination result which include: a) Examination result achievement b) Certified Persons Code of Conduct.

Candidate to:-- Reply the Acceptance of Agreement for Certified Persons Code of Conduct .

Notification on Examination Result

10 WORKING

DAYS

10 WORKING

DAYS

ACCB

ACCB &

Candidate



9.1 Application Process

Candidate shall submit complete application registration form and appropriate fees at

least 30 days in advance of the exam date. The application form can be found on

www.accbcertification.com

Applications are reviewed to verify information and documentation to determine

eligibility and will be kept confidential. Candidates will not be discriminated against

based on race, gender or national origin or ancestry.

Candidates who meet the application requirements will receive confirmation of their

acceptance into the examination and slip examination. They have 5 days to reply on

the agreement on the date of examination. Candidates who do not meet the application

requirements will receive a status via notification letter. The application may be

deemed incomplete for reasons such as:

Application is not completely filled up

Application is not signed

Appropriate fees are not submitted

Proper documentation is not submitted

If the application is denied, the candidate will receive notification letter or email stating

the reason for the denial. Candidates will have 7 working days to respond. The

application may be denied for reasons such as:

Failure to demonstrate eligibility in academic, work experience, or specialized

training

Falsification of any information on the exam application

9.2 Eligibility Appeals

Candidates will be notified through the notification letter regarding their status in the

certification program. If a candidate fails to meet the eligibility requirements for the

examination, the candidate has 7 working days to appeal the decision. The candidate

must submit the request in writing to the ACCB email at [email protected]

9.3 Examination Preparation

Candidates should notify ACCB at least 5 working days in advance of the examination

date for confirmation of attendance on exam date. All certification programs are self-

study.

9.3.1 Examination Content Outlines

Examination content outlines are available for every examination. Candidates

can find the outlines at the end of this handbook. The content outline provides

information such as the number and type of questions; how long the candidate

will have to complete the exam; what materials the candidate may bring to the

exam; and percentage of question per category.



9.3.2 Examination Day

All examinations will be carried out at our Authorized Examination Room

located at No 1-17, Perdana The Place, Jalan PJU 8/5G, Bandar Damansara

Perdana, 47820 Petaling Jaya, Selangor.

a) Candidate Check-in:

Candidates should also bring their Identification Card and Examination

Slip that contains their name, IC number, Registry Number, Seat Number,

Examination Date, Time and Venue and also Code of Certification. If the

candidate loses or does not receive his/her Slip Examination, please

contact ACCB at +60 3-7732 6056.

The candidate shall arrive at the Examination Room at least 15 minutes

prior to the exam starting time. Late arrivals will not be admitted to the

room and will be considered “no shows” and lose all exam fees paid.

b) Policies During Exam Administration

The following list is the policies that will be maintained during the

examination session:

Candidates are admitted only to their assigned test centre at their

assigned time.

No guests are permitted in the exam room.

No reference material, books, papers, translation aids, personal items

are allowed in the exam room.

No electronic devices, such as pager, cell phone or “smart “watches,

any device with internet access, or google glasses are allowed in exam

room.

No weapons may be brought into the exam room.

No test materials, documents, memos of any sort are allowed to be

taken from the exam room.

Candidates are not allowed to communicate with others test takers.

Invigilators are authorized to maintain a secure and proper test

administration.

Candidates will be given the opportunity to write comments about

exam items during the exam through the feedback form.

Candidates are provided scratch paper and a pencil during the exam.

Breaks are not allowed during the exam.

Food and beverage is not allowed in the exam room.

Candidates may not copy in writing, transmit or record exam questions

and/or answers of any exam material.



c) Policies After Completing the Exam

A candidate who completes the exam may leave the examination room

after returning all related exam materials. Please try to do this as quietly as

possible so that those still working on the exam will not be disturbed. The

administrator will make sure that the candidate returns all materials.

d) Inclement Weather

If a candidate in unable to arrive at the designated exam site because of

inclement weather, terrorist acts, natural disasters, or other unforeseen

emergencies beyond the control of the candidate as determined by ACCB,

the candidate will be allowed to take the next regularly scheduled exam

without being charged the examination fee.

If for any reason the exam is unable to be administered, then the exam will

be rescheduled within a reasonable period of time. Candidates may take

the exam at the next schedule without any additional cost. Candidates are

responsible for their own associated expenses.

9.3.3 Rescheduling an Examination

Candidates are only allowed to reschedule an examination once. Examination

rescheduled within five (5) working days of their scheduled examination date

will forfeit all examination fees provided ACCB is notified in writing by email

at [email protected]

Examination rescheduled beyond five (5) working days of their earlier

scheduled examination will be not been entertained.

9.3.4 Cancellation/Withdrawing Policy

A cancellation fee will be applied to the candidate who fails to cancel a

rescheduled examination within five (5) working business days before the

examination date. Cancellations must be made in writing and sent by email to

[email protected]

9.3.5 Failure to Appear

If a candidate does not appear to take a scheduled exam, the candidate will

forfeit all fees. All fees will need to be paid again if the candidate decides to

reschedule at a later date.




9.4 Security

Security Violations/Cheating

No spouses, children, parents, friends, or other outside parties are permitted near the

examination room. Upon completion of the examination, candidates must leave the

examination area immediately. Any candidate who gives or receives help during the

examination will be asked to leave and their examination will not be assessed.

Examination fees will not be refunded and the candidate may be prohibited from taking

ACCB examination for a specified period of time.

The performance of all candidates is monitored and may be analysed to detect fraud.

At any time after the examination administration should there be a question about score

validity or the identity of an examination candidate, the ACCB staff will investigate

and determine whether it is appropriate to void the exam score. The ACCB personnel

maintain and adhere to a security policy which is available to all personnel for the

administration of examination and maintaining the certification program.

9.5 Scoring and Results

a) Scoring Process

Examination are scored making every effort to ensure that the score is reported

within a reasonable time period and that the score accurately reflects the points

received by the candidate. Candidates are encouraged to give feedback on whole

examination process which can be related to a specific question; the administration

of the examination; or the examination room conditions. Feedback that would

affect whether a candidate passes or fails an examination will be reviewed before

the examination is scored. All other comments are reviewed by the ACCB

personnel at their regularly scheduled meetings. Feedback can be given via

Customer Feedback Form (CQF037).

b) Notification of Results

Candidates will be notified of their result status within 30 days. They will receive

an official ACCB Certificate of Competency if they passed the examination.

Candidates who fail an examination will be notified by ACCB and they are

allowable to apply for re-seat the examination for 2 times. But if still failed, the

candidates are required to attend related trainings before they can re-apply to seat

the examination. There is no refund for failed exams.

9.6 Change of Contact Information

It is the Certified Person’s responsibility to ensure that ACCB has their most current

contact information including, mailing address, phone number and email address.



9.7 Use of Certification Marks and Designations

a) Introduction

After receiving notification of earning a Certified Person, the credential(s) granted

may be used only as long as they remain the valid and in good standing in the field.

Certified Person may not use the credential(s) until they have received specific

written notification that they have successfully completed all requirements,

including passing the required exam(s). Certified Person must comply with all

recertification requirements to maintain use of the credential(s).

Individuals who fail to maintain ACCB certification / recertify or whose Certified

Person is suspended or revoked must immediately discontinue use of the

certification mark(s) and are prohibited from stating or implying that they hold the

Certified Person from ACCB.

b) Certification of Competency Certificate

Each Certified Person will receive a certificate for each credential granted. Each

certificate will include, at a minimum, the following information:

Name of the certification body

Name of the Certified Person

Unique certification number

Identification number

Scope of certification

Reference to certification scheme, standard or other relevant documents

Effective date of certification and date of expiry

Endorsement by authorized ACCB Personnel.

Certified Person who renew their certification (recertify) will receive a certification

renewal card and a renewal certification of competency certificate with a new

expiration date.

9.8 Maintaining Your Certification

a) Rationale

ACCB's goals for recertification are to ensure that ACCB Certified Person remain

current with best practices, broaden their understanding of the industry, and

continue to be recognized as the competent person of Biomedical Engineering

Maintenance (BEM). Given the moderate rate of change for the BEM field,

including the standards upon which it relies, ACCB believes a three-year

recertification cycle is appropriate.



b) Introduction

In a profession that regularly undergoes change; the importance of certification is

growing rapidly. The purpose of this program is to ensure that those who are

actively certified maintain a level of professional knowledge and skill, that is

consistent with the standards according to which certification was initially

conferred.

Certification is only as valuable as the standard it represents, if the standard is

maintained. Recertification programs are extremely important because they require

holders of the credential to present evidence that they are maintaining the

established standard. This, in turn, enables certification to retain meaning and value

for every individual who achieves it, particularly as the years pass after the

credential is issued.

10. Recertification Process Flow

Start

Application

Recertification

- Application Form (Certification/ Recertification)- Supporting Document *Passport – sized photograph *Employment Confirmation Letter by Employer *Copy of Competency Certificate *Copy of Safety Training Certificates *Copy of Regulatory Training Certificate *Copy of Technical Training Certificate *Copy of Soft Skill Training Certificate *Copy of Trainer Information such as CV / Training Brochure / etc *Copy of evidence as a trainer related to the competency - Application Fee *Payment Slip

Note: 1) Application for recertification must be done 2 months before expiry date stated in the competency certificate2) All copies of supporting document must be certified true copy by employer

Notification

NO

YES

- Review application form and supporting documents - Notification letter to unsuccessful Certified Person

- Issue Certificate of Competency and feedback form - Update Certification Registry - Notification letter to successful Certified Person

End

7 DAYS

- Notify applicant on acknowledgement of application

Certified Person

ACCB

ACCB

ACCB

Assessment

7 DAYS

30 DAYS

EXPLAINATIONPERSON

IN-CHARGE



10.1 Recertification

Certified person shall apply for recertification through the Application for

Certification/Recertification Form 2 months prior the expiry date as a certified person.

Certified Person is required to submit document (a) and (b) to ACCB as a confirmation

of continuing satisfactory work and work experience records:-

a) Record of job/work related to the competency for each year in three (3) years from

the date as a certified person.

(Minimum fifteen (15) records of planned preventive maintenance and fifteen (15)

breakdown repair attended.)

b) Professional development records

Option 1

N

o

Details

1.1 Copy of training certificate attended from any training provider:

- Related Soft skill training (8 hours in 36 months)

- Regulatory training (8 hours in 36 months)

- Safety Training (8 hours in 36 months)

- Technical training related to the competency (8 hours in 36 months)

1.2 Copy of training certificate attended from internal


1.3 Copy of evidence as a trainer related to the competency

- On job training / internal training / external training (30 hours in 36 months)

OR

Option 2

No Details

1.1 Copy of training certificate attended from any training provider:

- Related Soft skill training (8 hours in 36 months)

- Regulatory training (8 hours in 36 months)

- Safety Training (8 hours in 36 months)




10.2 Recertification Procedures

All Certified Person are required to submit the application form and all related training

certificates for recertification process three (2) months before from the expiry date.

They have to ensure application’s fee is paid and payment slip is attached together with

the submission.

Certified Person must immediately inform ACCB of matters that affect his/her

capability to continue to fulfil the certification requirements by email at

[email protected]

11. Complaint Process Flow

Start

Complaint

Withdraw

- Complaint medium – ACCB Complaint Form (CQF018) / Email / Fax / Letter / Phone Call

Related to Certification

Process

Non Related to Certification

Process

- Notify the accused Certified Person and the related company regarding the suspension

- Arrange and call the accused Certified Person for inquiry session- Prepare investigation report

End

1 DAYS

Complainant

ACCB

ACCB

ACCB Investigate

14 DAYS

EXPLAINATIONPERSON

IN-CHARGE

Receive

ValidateCorrective &

Preventive Action by ACCB

Suspended

Offence

Non Offence

- Receive and record complaint in Complaint Registry

- Notify the investigation finding to accused Certified Person and related parties- Certified Person who are found guilty are required to return the Competency Certificate

- Identify the complaint related to certification activities or not- If non related, Corrective and Preventive Action Procedure should been implement.

ACCB

ACCB

1 DAYS




11.1 Complaints Related to Certification Process

ACCB will be responsible for all complaints received among others but are not limited to

the following: -

Evidence of falsification of information provided on documents submitted to

ACCB.

Cheating on certification exams.

Evidence of non-compliance with the Code of Conduct.

Evidence of improper use of the ACCB certification status and/or logos

Violation of established ACCB certification policies, rules and requirements.

Conviction of a felony or other crime of moral turpitude under federal or state law.

Gross negligence, wilful misconduct, or other unethical conduct in the performance

of services for which the individual has achieved certification from ACCB.

ACCB has established procedures to fairly and consistently address alleged violations.

Disciplinary procedures are designed to ensure that valid and actionable complaints are

investigated and considered, and that all parties involved in the complaint have an

opportunity to document circumstances warranting the complaint and to respond to the

complaint.

All complaints will first be reviewed by the ACCB personnel. If the complaint can be

verified and resolved without further documentation or investigation, ACCB will notify

the complainant if necessary and the complaint will be closed.

If the complaint requires additional information or which cannot be easily closed, ACCB

will proceed with further investigation in 14 working days before any actions will be

taken. Meanwhile, during the investigation period, the personnel will be suspended in

writing from the certification and if required, the personnel will need to be cooperated

with ACCB such as attend for some inquiry sessions.

Following the investigation, ACCB will inform the complainant of the decision in

writing. The complainant will be notified in writing that a decision was reached. If

disciplinary action is imposed, the complainant may submit an appeal of the decision to

ACCB. This appeal must be submitted in writing to the ACCB. A signed appeal must be

submitted in writing within 14 working days from receipt of the written notification that

a disciplinary action is imposed and must clearly state the grounds for appeal. Below are

two possible decisions that ACCB may make in regards to a complaint.

a) Withdrawal/Revocation

When a complaint is received by ACCB which upon investigation by the policies

and processes laid out appears to be due to negligence or intentional malpractice or

violation of the code of conduct, the ACCB may withdraw certification. In the event

of withdrawal, the Certified Person must refrain from further use of all references to

certified status.



b) Suspension

When a complaint is received by ACCB which upon investigation by the policies

and processes laid out appears to be due to accidental causes, unintentional

negligence or oversight, the ACCB may suspend the Certified Person certification

for a specific period. ACCB may establish monitoring procedures during the

suspension which the Certified Person must conform to. During the time of

suspension, the Certified Person must refrain from further promotion of his or her

certification. If the Certified Person does not remedy the conditions of the

suspension, the Certified Person certification may be withdrawn.

11.2 Complainant

Applicant/candidates/Certified Person or other individuals within industry can do a

complaint by fill up a complaint form.

12. Special Arrangement

12.1 Request special arrangement

Candidates are allowed to request for special arrangement in the Application for

Certification/Recertification Form (CQF031) by giving a reasonable justification

of request and special arrangement include: -

a) Accommodation with additional cost

b) Wheelchair assistance

c) Hearing aid assistance

ACCB will give the feedback within 10 working days after received the application

form. However, candidate is still allowed to request for special arrangement within

5 days upon receiving the notification letter of examination. ACCB will do a

necessary review and arrangement for specific request made.

The request shall be supported with relevant documentation such as letter from a

physician or other qualified professional reflecting a diagnosis of the candidate’s

condition and explanation of exam aids or modifications needed. Kindly take notes

all cost incurred shall be borne by candidate.

12.2 Request on site Examination

ACCB also allowed any special request on special Examination Centre

arrangement.Your employer shall make a request in writing to ACCB for this

request, and we may proceed with this condition: -

a) All cost incurred on ACCB invigilator are bill to client such as travelling

expenses, accommodation, logistic, etc

b) Client are required to follow Examination Guideline – seating

arrangement, security of Examination Room, etc

c) Client shall make a request 2months prior propose examination date



13. Appeal Process

For appeal process candidate has to provide minimum requirement as follows: -

Appeal letter

Examination result (applicable for item 17.1 (A))

Withdrawing and/or reducing the scope of certification result (applicable for item 17.1(B))

Fee amounting RM1,000.00 per application

13.1 Type of Appeal

a) Appeal for examination result

Candidate may appeal for ACCB to review examination result, within 14 working

days from the announcement of the examination result.

b) Appeals for withdrawing and/or reducing the scope of certification result

In addition to appeals of disciplinary action, an individual or Certified Person who

was denied certification or had his/her certification revoked may file an appeal

within 14 working days of receipt of notice of the action taken that is eligible for

appeal.

13.2 Appeals Body

The Scheme Committee (SC) is the appeals body that hears appeals. The SC is the final

body to hear an appeal and there are no further appeals once the full SC has acted. The

SC ruling is final.

13.3 Scheme Committee Consideration of the Appeal

The SC reviews all properly filed and documented appeals to determine if significant

evidence exists of a substantive error or omission in the certification process or

outcome. When the SC reaches a decision, the appellant will be notified in writing

within 30 days of such decision being made.

14. Confidentiality

ACCB will release the candidate’s result ONLY to individual. Any question concerning result,

should be referred to ACCB.

ACCB shall kept all information related to candidate as CONFIDENTIAL and it shall not be

disclosed to third party without Certified Person consent.



15. Examination

15.1 BEM-BDIA01

SCHEME OUTLINES

1.0 Introduction of diagnostics equipment (15%)

1.1 Theory and understanding of diagnostics equipment classification

1.2 Theory and understanding of anatomy and physiologic

1.2.1 Organ function

1.2.2 System body related to the diagnostics equipment

1.2.3 Diseases

2.0 Functions & Operations (30%)

2.1 Group C (Diagnostic)

No Group Description (UMDNS)

1 Airflow Detectors,

Airway Airflow Detectors, Airway

2 Analysers, Point-of-

Care Analyzer, Point-of-Care, Breath, Alcohol

3

Balances

Balances, Mechanical

4 Scales, Clinical, Autopsy

5 Scales, Clinical, Blood Collection

6 Scales, Clinical, Laboratory

7 Scales, Infant

8 Scales, Patient, Chair

9 Scales, Patient, Floor

10 Calipers

Calipers

11 Calipers, Skinfold, Manual

12 Dialysis Dialysate Conductivity Meters

13

Endoscopy

Laryngoscopes

14 Laryngoscopes, Rigid

15 Printers, Video

16

Eye Equipment

Charts, Eye

17 Charts, Eye, Visual Acuity

18 HESS Chart

19 Magnets, Eye

20 Ophthalmoscopes

21 Ophthalmoscopes, Direct

22 Ophthalmoscopes, Indirect

23 Projectors, chart eye

APPENDIX 1



SCHEME OUTLINES


24

Fetal Heart Detectors

Fetal Heart Detectors

25 Fetal Heart Detectors, Phono

26 Fetal Heart Detectors, Ultrasonic

27

Light Sources

Light Sources

28 Light Sources, Fiberoptic

29 Light Sources, Fiberoptic, Flexible Endoscopic

30 Light Sources, Fiberoptic, Rigid

Endoscopic/Multipurpose

31 Light Sources, Microscope

32 Ophthalmoscopes/Oto

scope Ophthalmoscopes/Otoscopes

33

Recorders

Recorders, Graphic, Evoked Potential

34 Recorders, Graphic, Evoked Potential, Auditory

35 Recorders, Graphic, Evoked Potential,

Somatosensory

36 Recorders, Graphic, Evoked Potential, Visual

37 Recorders, Graphic, Physiologic, Anesthesia

38 Recorders, Graphic, Trend, Heart Rate

39 Recorders, Graphic, Trend, Temperature

40 Recorders, Tape, Data, Blood Pressure

41 Recorders, Tape, Data, Electrocardiography

42 Recorders, Tape, Data, Physiologic

43 Recorders, Tape, Video

44 Recorders,Graphic, Trend, Blood Pressure

45

Sphygmomanometers

Sphygmomanometers

46 Sphygmomanometers, Aneroid

47 Sphygmomanometers, Electronic

48 Sphygmomanometers, Electronic, Automatic

49 Sphygmomanometers, Electronic, Manual

50 Sphygmomanometers, Mercury

51 Thermometers

Thermometers, Electronic, Infrared, Ear

52 Thermometers, Electronic, Infrared, Skin

53 Transilluminators Transilluminators

54 Treadmills Treadmills

55 Uroflowmeters Uroflowmeters

56 Vacuum Electrode

System Vacuum Electrode System



SCHEME OUTLINES

3.0 Safety (15%)

3.1 Safety features for the diagnostics equipment

3.2 Electrical Safety Test

4.0 Service and Repair (30%)

4.1 Plan Preventive Maintenance Procedure

4.2.1 Asset Details

4.2.2 Special Precaution

4.2.3 Test Apparatus

4.2.4 Qualitative Tasks

4.2.5 Preventive Maintenance Tasks

4.2.6 Quantitative Tasks

4.2.7 Electrical Safety Test

4.2 Repair

4.3.1 Identification of the common problems

4.3.2 Troubleshoot and repair minor defect related to power

supply

4.3.3 Spare part identification

5.0 Managing (10%)

5.1 Understanding on Biomedical Engineering related documentation

5.1.1 Testing and Commissioning

5.1.2 Management of Warranties

5.1.3 Schedule Maintenance

5.1.4 Unscheduled Maintenance

5.1.5 Risk Management



15.2 BEM-BTHE01

SCHEME OUTLINES

1.0 Introduction of Therapeutic Equipment (15%)

1.1 Theory and understanding of therapeutic equipment classification



1.2.2 System body related to the therapeutic equipment

1.2.3 Diseases


2.1 Group D (Therapeutic)

No Group Description ( UMDNS)

1 Aerosol Generators Aerosol Generators

2 Analgesia units Analgesia Units

3 Analgesia units Analgesia Units, Inhalation

4 Aspirators

Aspirators

Aspirators, Dental

Aspirators, Emergency

Aspirators, Infant

Aspirators, Liposuction

Aspirators, Low Volume

Aspirators, Surgical

Aspirators, Thoracic

Aspirators, ultrasonic

5 Baths Baths, Portable

6 Baths, Paraffin, Physical

Therapy Baths, Paraffin, Physical Therapy

7 Baths, water

Bath, Water, Plasma-Thawing

Baths, Water, Molded Plastic Splint

Baths, Water, Shaker

8 Battery Chargers Battery Chargers

9 Bilirubinometers,

Cutaneous Bilirubinometers, Cutaneous

10 Cast cutters

Cast cutters

Cast Cutter Vacuums

Cast Cutters, Electric

11 Compression Units Compression Units, Intermittent

Compression Units, Intermittent, Cryotherapy

APPENDIX 2



SCHEME OUTLINES


12 Dental Equipment

Acrylic Curing Units, Dental

Amalgamators

Carriers, Dental, Cement/Paste, Root Canal, Powered

Carvers, Dental

Casting Furnaces, Dental

Casting Units, Dental

Compressors, Medical-Air

Dental Handpiece Maintenance Unit

Fume Evacuators, Dental

Micromotor, Dental

Modular Medical Facilities, Mobile, Dental

Perimeters

Polishing unit, Dental

Polymer Applicator, Dental

Presses, Flask, Dental

Sandblaster, Dental

Scalers, Dental, Ultrasonic

Testers, Pulp

Trimmers, Model, Dental

Vacuum-Mixing Devices, Dental

Welding Units, Orthodontic

13 Dialysis Baths, Dialysate Warming

14 Dynamometers Dynamometers

15 ENT Equipment Trainers, Auditory

16 Ergometres Ergometers

Ergometers, Bicycle

17 Exercisers, continuous

passive motion

Exercisers, continuous passive motion

Exercisers, Continuous Passive Motion, Lower Limb

18 Eye Equipment Chairs, Examination/Treatment, Ophthalmology

Pressure Reducers, Intraocular

19 Flowmeters Flowmeters

Flowmeters, Gas

20 Heating Units

Heating Blocks

Heating Pads

Heating Units

Heating Units, Hot-Pack

Heating Units, Thermal Probe

Heating Units, Wax Scalding Unit

Moist Heat Therapy Pack Conditioners



SCHEME OUTLINES


21 Infusion Devices

Intraosseous Infusion Kits

Pressure Infusors

Pumps, Enteral Feeding

Pumps, Extracorporeal Perfusion

22 Injectors,

Medication/Vaccine

Injectors, Medication/Vaccine

Injectors, Medication/Vaccine, Needleless

23 Lights Headlights

24 Lights, Dental Lights, Dental

Lights, Dental, Intraoral

25 Lights, Infrared Lights, Infrared

26 Lights, Surgical Lights, Surgical

27 Lights, Ultraviolet Lights, Ultraviolet

Lights, Ultraviolet, Germicidal

28 Massage Machines,

Physical Therapy Massage Machines, Physical Therapy

29 Mattress Systems Mattress Systems, Low-Air-Loss

Mattress Systems, Alternating-Pressure

30 Nebulizers

Nebulizers

Nebulizers, Heated

Nebulizers, Nonheated

Nebulizers, Ultrasonic

31 Photometers Photometers

32 Phototherapy Units

Phototherapy Units

Phototherapy Units, Ultraviolet

Phototherapy Units, Visible

Light, Hyperbilirubinemia

33 Pumps, Alternating-

Pressure Pad Pumps, Alternating-Pressure Pad

34 Pumps, Breast Pumps, Breast

35 Resuscitators Resuscitators

36 Resuscitators, Pulmonary

Resuscitators, Pulmonary, Exhaled Air

Resuscitators, Pulmonary, Manual

Resuscitators, Pulmonary, Manual, Reusable

Resuscitators, Pulmonary, Pneumatic

37 Saws

Saws, Autopsy

Saws, Bone

Saws, Bone, Electrical

Saws, Bone, Pneumatic

38 Stimulator Analyzers Stimulator Analyzers, Transcutaneous Nerve

39 Stimulators, Caloric

Stimulators, Caloric, Physical Therapy, Fluidized

Medium

Stimulators, Caloric, Vestibular Function

40 Tables/ Beds Tables, Operating



SCHEME OUTLINES


41 Tourniquets

Tourniquets

Tourniquets, Pneumatic

Tourniquets, Pneumatic, Automatic Rotating

42 Traction Units

Traction Units

Traction Units, Intermittent

Traction Units, Static, Bed

43 Training Aids Training Aids

44 Training Manikins Training Manikins, Cardiopulmonary Resuscitation

45 Ultrasound Cleaning

Systems Ultrasound Cleaning Systems

46 Vacuum Extractors Vacuum Extractors, Obstetrical

47 Vibrators Vibrators

48 Warming Units

Warming Units

Warming Units, Blanket

Warming Units, Blood/Solution

Warming Units, Contrast Media

Warming Units, Microscope Slide

49 Warming Units, Patient

Warming Units, Patient

Warming Units, Patient, Circulating-Fluid

Warming Units, Patient, Forced-Air

Warming Units, Patient, Radiant

Warming Units, Patient, Radiant, Adult

Warming Units, Patient, Radiant, Infant

Warming Units, Patient, Radiant, Infant, Mobile

50 Washers Washers, Cell

3.0 Safety (15%) 3.1 Safety features for the Therapeutic equipment


4.0 Service and Repair (30%) 4.1 Plan Preventive Maintenance Procedure

4.1.1 Asset Details







4.2 Repair



supply




SCHEME OUTLINES

5.0 Managing (10%)









15.3 BEM-BLAB01

SCHEME OUTLINES

1.0 Introduction of Laboratory Equipment (15%)

5.2 Theory and understanding of laboratory equipment classification



1.2.5 System body related to the laboratory equipment

1.2.6 Diseases


2.1 Group B (Laboratory)


1 Air Samplers Air Samplers

2 Balances Balances

3 Baths, Water

Baths

Baths, Water

Baths, Water, Laboratory

Water Bath Circulators

4 Bilirubinometers Bilirubinometers

5 Bone Mills Bone Mills

6 Bunsen Burners Bunsen Burners

7 Calibrators Calibrators

8 Centrifuges Centrifuges

Centrifuges, Floor

Centrifuges, Tabletop

Centrifuges, Tabletop, High-Speed,

Microhematocrit

Centrifuges, Tabletop, High-Speed, Micro-Sample

9 Chambers, Anaerobic Chambers, Anaerobic

10 Concentrators, Specimen Concentrators, Specimen

11 Diluters Diluters

Diluters, Blood Cell

12 Dispensers Dispensers

Dispensers, Fluid

Dispensers, Liquid, Laboratory

13 Dryers, Slide Dryers, Slide

14 Evaporators Evaporators

15 Fluorometers Fluorometers

16 Hot Plates Hot Plates

17 Hygrometers Hygrometers

18 Incubators, Laboratory Incubators, Laboratory, Shaker/Rotator, Platelet

Incubators, Test Tube

Incubators, Test Tube, Portable

APPENDIX 3



SCHEME OUTLINES


19 Mixers Mixers

Mixers, Blood Bank, Donor Blood

Mixers, Blood Tube

Mixers, Clinical Laboratory

20 pH Meters pH Meters

21 pH Monitors pH Monitors

22 Pipetters Pipetters

23 Pumps, Laboratory Pumps, Laboratory

24 Rotators Rotators

25 Sedimentation Rate Units Sedimentation Rate Units

26 Separators Separators

Separators, Plasma

27 Shakers Shakers

Shakers, Laboratory

28 Slide Stainers Slide Stainers

Slide Stainers, Histology

29 Stirrers Hot Plate/Stirrers

Stirrers

30 Strippers, Donor Tube Strippers, Donor Tube

31 Timers Timers, Other

32 View Boxes View Boxes, Microtiter

View Boxes, Ultraviolet

33 Water Purification Systems Water Purification Systems

Water Purification Systems, Deionization

Water Purification Systems, Ultraviolet

3.0 Safety (15%)

3.1 Safety features for the laboratory equipment




4.2.1 Asset Details







4.2 Repair



supply




SCHEME OUTLINES

5.0 Managing (10%)









15.4 BEM-ITHDU02

SCHEME OUTLINES

1.0 Introduction of Dialysis (15%)

1.1 Theory and understanding of active medical device classification

1.1.1 Group D (Therapeutic-Dialysis)


1.2.1 Organ function (kidney)

1.2.2 System body related to the medical device (Urinary)

1.2.3 Diseases


2.1 Group D (Therapeutic-Dialysis)

2.1.1 Dialyzer Reprocessing Units

2.1.2 Haemodialysis Unit Conductivity Monitors

2.1.3 Haemodialysis Units

2.1.4 Hemofiltration Units

2.1.5 Peritoneal Dialysis Units

2.1.6 Water Purification Systems, Reverse Osmosis

2.1.7 Water Purification Systems, Reverse Osmosis,

Haemodialysis, Portable

3.0 Safety (15%)

3.1 Safety features for the Dialysis and related equipments



4.1 Identify and Understand on Plan Preventive Maintenance Procedure

4.1.1 Asset Details







4.2 Repair



supply


4.2.4 Repair and replacement of equipment modules, assemblies

or boards (PCB)

4.2.5 Equipment calibration requirement

4.2.6 Repair and replacement of component or subcomponent of

the equipment PCB

APPENDIX 4



SCHEME OUTLINES

5.0 Managing (15%)

5.1 Understanding on Biomedical Engineering Maintenance Service

Management:

5.1.1 General technical support and facilities

5.1.2 Schedule maintenance management

5.1.3 Unscheduled maintenance management

5.1.4 Communication skill

5.1.5 Biomedical Engineering Services

5.1.6 Biomedical Engineering Services administrative function



15.5 BEM-ITVEN02

SCHEME OUTLINES

1.0 Introduction of Ventilators (15%)

1.1 Theory and understanding of active medical device classification

1.1.1 Group D (Therapeutic-Ventilators)


1.2.1 Organ function (Lung)

1.2.2 System body related to the medical device (Respiratory)

1.2.3 Diseases


2.1 Group D (Therapeutic-Ventilator)

2.1.1 Continuous Positive Airway Pressure Units

2.1.2 Ventilators

2.1.3 Ventilators, Anaesthesia

2.1.4 Ventilators, Intensive Care

2.1.5 Ventilators, Intensive Care, Adult

2.1.6 Ventilators, Intensive Care, Adult, High-Frequency

2.1.7 Ventilators, Intensive Care, Neonatal/ Paediatric

2.1.8 Ventilators, Intensive Care, Neonatal/ Paediatric, High-Frequency

2.1.9 Ventilators, Portable/Home Care

2.1.10 Ventilators, Transport

2.1.11 Humidifiers, Heated

3.0 Safety (15%)

3.1 Safety features for the medical devices




4.1.1 Asset Details







4.2 Repair


4.2.2 Troubleshoot and repair minor defect related to power supply


4.2.4 Repair and replacement of equipment modules, assemblies or boards

(PCB)

4.2.5 Equipment calibration requirement

4.2.6 Repair and replacement of component or subcomponent of the

equipment PCB

APPENDIX 5



SCHEME OUTLINES

5.0 Managing (15%)

5.1 Understanding on Biomedical Engineering Maintenance Service

Management:

5.1.1 General technical support and facilities

5.1.2 Schedule maintenance management

5.1.3 Unscheduled maintenance management

5.1.4 Communication skill

5.1.5 Biomedical Engineering Services documentation

5.1.6 Biomedical Engineering Services administrative function



15.6 BEM-OEST03

SCHEME OUTLINES

1.0 Objective of performing Electrical Safety Testing

2.0 Physiological Effects / Shock Hazards

3.0 Standards Requirements

3.1 MS 2058:2009

3.2 IEC 60601

3.3 IEC 62353

3.4 IEC 61010

4.0 Classification of Active Medical Equipment

5.0 Type of Applied Part in Medical Equipment

6.0 Limit and Parameters:

6.1 IEC 60601

6.2 IEC 62353

6.3 IEC 61010

7.0 Electrical Safety Testing for:

7.1 Internal Electrical Power Source

7.2 Fix Wired and 3 phase

APPENDIX 6

CERTIFICATION HANDBOOK (CHB001) - ACCB Certification |

Documents

Transcript of CERTIFICATION HANDBOOK (CHB001) - ACCB Certification |