Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
STANDARD
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
ICS: 11.040.01
Descriptors: medical electrical equipment, code of practice, Biomedical Engineering, maintenance,
services, active medical device
© Copyright 2009
DEPARTMENT OF STANDARDS MALAYSIA
DEVELOPMENT OF MALAYSIAN STANDARDS
the public, protecting the consumers, facilitating domestic and international trade and
furthering international cooperation in relation to standards and standardisation.
http://www.standardsmalaysia.gov.my http://www.sirim.my
E-mail: central@standardsmalaysia.gov.my
MS 2058:2009
CONTENTS
Page
1 Scope……….………………………………………………………………………….… 1
2 Normative references …….…………………………………………………………… 1
3 Definitions……………………………………………………………………………….. 1
4 General………….………….…………………………………………………………… 5
5 Responsibilities…………………………………………………………………………. 6
6 Scheduled maintenance…………………………………………………………..…... 8
7 Unscheduled maintenance …………………………………………….………..…..... 13
8 Acceptance testing...………….……………………………………………………….. 14
9 Mechanisms to avoid failure or breakdown during use …………………………... 15
10 Uptime…………………………………………………………………………………… 16
11 Quality assurance program (QAP)….……..…………………………………………. 17
12 Maintenance management information system (MMIS)..…………….……………. 18
13 Management of warranties………………………………………………………….… 18
14 Decommissioned equipment………………………………………………………….. 19
15 Disposal of equipment…………………………………………………………………. 19
16 Processes for handling hazardous/contaminated equipment …………………….. 20
17 Incidents and hazards …………………………………………………………………. 20
18 User training ……………………………………………………………………………. 21
19 Stock of genuine spares ………………………………………………………………. 21
20 On-site library …………………………………………………………………………... 22
21 Workshop setup………………………………………………………………………… 22
22 Advisory service………………………………………………………………………... 24
23 Procurement of equipment ………………………………………………………….... 26
Tables
CONTENTS (continued)
Page
Figures
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
A1 Competency level………………………………………………………………………. 30
B1 Asset label number…………………………………………………………………….. 48
B2 Maintenance status………………………………………………….…………………. 48
B3 Equipment under warranty…………………………………………………………….. 49
B4 Proposed for disposal/exemption…………………………………………………….. 49
B5 Danger tag ……………………………………………………………………………… 50
B6 Equipment under observation…………………..…………………..………………… 50
J1 Example layout for a maximum of two personnel…………….…………………….. 65
J2 Example layout for a maximum of six personnel……………………………….…… 66
Annexes
Committee representation
The Industry Standards Committee on Medical Devices and Facilities for Healthcare (ISC R) under whose authority
this Malaysian Standard was developed, comprises representatives from the following organisations:
The Technical Committee on Code of Practice of Active Medical Devices and Low-Voltage Electrical
Equipment/System for Healthcare Facilities which developed this Malaysian Standard consists of representatives
from the following organisations:
FOREWORD
This Malaysian Standard was developed by the Technical Committee on Code of Practice of
Active Medical Devices and Low-Voltage Electrical Equipment/System for Healthcare
Facilities under the authority of the Industry Standards Committee on Medical Devices and
Facilities for Healthcare.
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
This Malaysian Standard is the first revision of MS 2058, Code of Practice for Good
Engineering Maintenance Management of Active Medical Devices.
f) sub-clause 5.2 p) regular monitoring of hazards and alerts relating to medical devices,
was added;
q) incorporation of new Figure J2, to give an example workshop setup for a maximum of
six personnel.
Compliance with a Malaysian Standard does not of itself confer immunity from legal
obligations.
1. Scope
This Malaysian Standard applies to all active medical device placed for use in any healthcare
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
facility or any other facility which requires maintenance. This standard is not applicable for
medical equipment placed and used in any facility not intended to be used on human.
2. Normative references
The following normative references are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the normative reference (including any amendments) applies.
MS IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
MS IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 1: General requirements
MS IEC 62353, Medical electrical equipment - Recurrent test and test after repair of medical
electrical equipment
3. Definitions
For the purposes of this standard, the following definitions apply.
Acceptance testing is qualitative and quantitative tests carried out on the medical device upon
completion of installation and prior to use for clinical service, to ensure its safety and
performance is in accordance with manufacturer’s specifications, purchase agreement, and
statutory requirements.
Any medical device, operation of which depends on a source of electrical energy or any
source of power other than that directly generated by the human body or gravity and which
acts by converting this energy. Medical devices intended to transmit energy, substances or
other elements between an active medical device and the patient, without any significant
change, are not considered to be active medical devices (Source: GHTF Document N15
dated June 27 2005).
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
The actions taken to restore the defect in the operation or the usage of equipment
usually detected by the user who takes the equipment out of clinical use.
The actions performed to restore an item to a specified condition when it fails to function as
per manufacturer’s specification. Corrective maintenance includes routine corrective
maintenance, breakdown maintenance and emergency maintenance.
3.7 Competence
The percentage of time during which a particular medical equipment is not available from a
minimum number of "common functional units" in a ward, a department or a specific area.
Downtime does not include upgrading time or the time when the medical equipment is not
required to be available.
An individual who owns and uses medical equipment for personal care.
Any premises in which one or more members of the public receive healthcare services, which
includes:
a) medical, dental, nursing, midwifery, allied health, pharmacy, and ambulance services
and any other service provided by a healthcare professional;
c) any service for the screening, diagnosis, or treatment of persons suffering from, or
believed to be suffering from, any disease, injury or disability of mind or body;
f) any service for curing or alleviating abnormal condition of the human body by the
application of any apparatus, equipment, instrument or device or any other medical
technology; or
3.14 In service
A planned maintenance program which specifies frequency, tasks and activities to be done in
order to ensure that all equipment is operating as per manufacturer’s specifications and is in
safe working condition.
3.19 Self-inspection
The percentage of time during which a particular Biomedical Engineering Service is available
from a minimum number of "common functional units" in a ward, a department or a specific
area. Uptime includes upgrading time and the time when the biomedical equipment is not
required to be available.
The percentage of time during which a particular piece of medical equipment is performing or
is available to perform its intended function. Uptime includes upgrading time and the time
when the medical equipment is not required to be available.
The list of uptime percentage predetermined based on healthcare facility authority agreed
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
3.24 Warranty
Scope of services and liability coverage by the supplier of medical equipment within a
contractual/defined period.
4. General
4.1 Maintenance consists of scheduled maintenance and unscheduled maintenance. The
former includes servicing undertaken by the user in the sequence and intervals indicated in
the instructions for use, a periodic maintenance performed by the Biomedical Engineering
Services, by an outside maintenance firm preferably approved by the manufacturer, or by the
manufacturer himself or his agent.
4.2 The equipment maintenance program ensures equipment is serviceable, safe, and
properly configured. The maintenance of equipment shall include:
4.3 The reason for servicing equipment is to maintain its usability in such a way that:
b) the equipment is safe for the patient and for the user; and
5. Responsibilities
These responsibilities are furnished as minimum requirements and are not intended to limit
management functions to the areas.
5.1 The healthcare facility authority shall ensure the healthcare facility comply with
international/national electrical safety standards (e.g. MS IEC 60364-7-710). Healthcare
facilities shall ensure that the active medical devices to be purchased conform to MS IEC
60601-1.
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
b) obtain required facilities and equipment for the organisation’s maintenance program;
d) plan for equipment support in the conceptual phase of each new equipment system;
f) develop and publish local policies and operating instructions (OI) as required;
k) outsource maintenance service of those systems when there are no adequate training,
tools, test equipment, and staff;
l) ensure that all ionising radiation emitting equipment maintenance comply with the
Atomic Energy Licensing Act 304 and MS 838;
n) perform a customer survey at least annually to determine the adequacy, quality, and
effectiveness of maintenance support and the degree of compliance;
o) assist in investigation of equipment adverse events and near incidents when requested;
and
b) register with the Board of Engineers as per specified in the Registration of Engineers
Act 1967 Revision 2002 as appropriate;
d) care for and upkeep the equipment to ensure it is always operating properly and in
serviceable condition;
g) not attempt repairs beyond the operating techniques described in the user’s manual;
k) be aware of conditions that may injure the patient or damage the equipment;
p) properly place the equipment during use, store and protect the equipment; and
5.5 Home users shall ensure that only competent individual/organisation carry out
maintenance on their equipment, in accordance with this standard. In the event that the home
user brings the equipment to the healthcare facility, it will/will not be subjected to maintenance
by the Biomedical Engineering services depending on the policy of the healthcare facility,
where applicable.
6. Scheduled maintenance
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
6.2.2 Calibration
Calibration is the measurement and adjustment of various device parameters to ensure its
accuracy within prescribed standards.
Responsibility of the equipment user department to carry out the basic maintenance on
routine basis such as daily, weekly or monthly activities to ensure condition and functionality
of the equipment are maintained as recommended by the manufacturer.
6.3 The minimum scheduled maintenance frequencies shall be developed based on the
following guidelines.
6.3.3 Area of use, equipment user experience and patient risk assessment subject to user
recommendation and approval by the Ministry of Health Malaysia.
6.3.4 Biomedical Engineering Services personnel shall perform the scheduled maintenance
at these minimum frequencies and may increase scheduled frequencies when appropriate.
6.3.5 Scheduled maintenance frequencies shall not be reduced without written approval of
the healthcare facility authority. The schedule changes shall not adversely affect patient care
or user and patient safety.
6.4 The individual equipment scheduled maintenance activity checklist shall be established
from the following sources:
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
6.5 The scheduled maintenance workload shall be programmed and distributed evenly
throughout the year, taking into consideration the following constraints:
a) peak workloads and periods when personnel may be absent due to training, leaves,
holidays, deployments, exercises, etc;
b) availability of test equipment and special tools, taking into consideration the test
equipment calibration requirement;
d) whenever possible, the scheduled PPM and calibration execution date shall be
concurrently programmed in order to increase efficiency.
b) better conservation of assets and increased life expectancy of assets, thereby eliminating
premature replacement of system and equipment;
c) reduced overtime costs and more economical use of maintenance workers due to working
on a scheduled basis instead of an ad hoc basis to repair breakdowns;
e) reduced cost of repairs by reducing secondary failures. When parts fail in service, they
usually damage other parts;
f) identification of equipment with excessive maintenance costs; indicating the need for
corrective maintenance, user training, or replacement of obsolete equipment; and
6.6.2 PPM is the joint responsibility of equipment user and Biomedical Engineering
Services.
6.6.3 The Biomedical Engineering Services personnel shall perform the following
qualitative, preventive and quantitative activities as stated in PPM checklist on each regular
inspection/maintenance of equipment where applicable (an example of a PPM is in Annex C).
a) Performance test
The medical equipment electrical safety test shall conform to MS IEC 62353. It describes
electro-medical equipment according to the type of protection provided against electric
shock (defined as Class I, II, or III), and the degree of protection provided against electric
shock (defined as Type B, BF, or CF). During PPM inspections, the Biomedical
Engineering Services personnel shall perform a general safety inspection on all
equipment and an electrical safety test, if applicable. In addition to pass or fail, numerical
results of the electrical safety inspections shall be recorded.
i) Clean the equipment in areas not normally accessible to the user, and clean internal
components including blowers, filters, fans, and coils (remove corrosion, dirt,
solutions, dust, lint, blood, or deposits.).
ii) Lubricate the unit, including motors, gears, bearings, casters, and other moving
components. Use only non petroleum-based, non-flammable lubricants on equipment
that uses oxygen.
iii) Inspect and service or replace as necessary, batteries and battery compartments.
iv) Service or replace all consumable devices such as filters and tubing.
v) Align and tighten all moving components not specifically covered in the calibration
procedures, such as doors, drawers, panels, shelves, catches, latches, casters, and
hinges.
The non-measurable tasks to ensure the quality of the equipment component or fixtures are in
good conditions, such as:
a) verify or test the equipment component, sub-component, accessories and any other
related feature on its physical and functionality conditions; and
6.6.4 The Biomedical Engineering Services shall propose the maintenance time required
and provide annual PPM schedule for all equipment. The user shall be given a copy of the
yearly plan schedules.
6.6.5 The user shall inform Biomedical Engineering Services if there is any change in
equipment location and any unavailability of equipment due to usage for the purposes of PPM
rescheduling.
6.6.6 Biomedical Engineering Services shall request for approval from the user department
for any rescheduling of PPM.
6.6.7 PPM should be performed with the component and accessories designated to the
item being serviced.
6.6.8 Equipment which fails testing and/or inspection shall not be used until deficiencies
are corrected. User shall be notified of the anticipated time of repair. Portable equipment shall
be removed from use until repairs are completed. Equipment shall be tagged as “out of
service” and user will confirm by signing the tag. Sample of tag is per Annex B.
6.6.9 When an item of equipment is well functioning but fails to meet the appropriate safety
standards, affix a danger tag to the equipment until the problem is corrected. Sample of tags
are as per Annex B.
6.6.10 The Biomedical Engineering Services personnel shall notify the user about the
danger tag and remove the equipment from use.
6.6.11 PPM record shall be maintained for the life of the device.
6.6.13 PPM work instruction shall refer to the manufacturer’s service manual. In the
absence of the manufacturer’s work instruction, document from an established organisation
shall be referred.
6.7 Calibration
For specialised medical devices such as vaporisers and X-ray equipment, calibration
certificates shall be maintained.
The calibration shall be carried out by approved or authorised calibration centre conforming to
nationally/internationally recognised accreditation body.
Biomedical Engineering Services personnel are to ensure test equipment used for calibration
of equipment is calibrated according to manufacturer’s specifications.
6.7.2 Biomedical Engineering Services personnel shall record and document all
calibrations on the appropriate form or work sheet (PPM checklist). All calibration records and
certificates shall be filed and kept by Biomedical Engineering Services and copy shall be
provided to the user upon request.
6.7.3 Biomedical Engineering Services personnel shall enter the appropriate information for
a completed calibration into the MMIS system or on the work order form.
6.7.4 The Biomedical Engineering Services personnel shall affix the calibration
certificate/PPM tag/sticker in a location visible to the user.
6.8.1 User maintenance is important for effective operation of medical equipment. It helps
prevent deterioration, defects and will increase the life of the equipment and its components.
6.8.2 The healthcare facility shall establish a schedule for routine inspection and user
maintenance based on either manufacturer recommendation or standard practices.
6.8.3 The user shall have a user maintenance program to assure clean, sanitised, safe
and functioning equipment. Part of the user maintenance activities are regular cleaning,
disinfection, inspection, proper storage, etc.
Equipment shall be cleaned and sanitised using recommended procedures given by the
manufacturer or departmental standard operating procedures (if any).
b) Inspection
The user shall ensure the equipment is inspected before each use and after cleaning;
and check equipment functionality, tightness of connections and condition of parts
(including accessories).
c) Storage
All equipments are to be stored in a clean and proper location to protect them from
damage, contamination, dust, sunlight, extreme temperatures, excessive moisture,
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
6.8.4 User that performs user maintenance at any circumstances shall not attempt to
repair beyond those specified in the operation manual. User shall report all defects or faults
and all repairs or adjustments are only to be carried out by Biomedical Engineering Services.
6.8.5 User maintenance training shall be given to the user either by the
manufacturer/agent or Biomedical Engineering Services as required or as requested by the
user.
7. Unscheduled maintenance
7.1 Biomedical Engineering Services shall ensure that all requests for unscheduled
maintenance are entered into the MMIS system.
7.2 Biomedical Engineering Services shall assign work based on a priority system to each
request.
7.3 While the priority of repair is determined locally, factors such as the type and
importance of the equipment, availability of alternate equipment, and the effect of downtime
on the medical service should be considered.
7.4 If the repair involves ordering repair parts, the Biomedical Engineering Services shall
list all required parts on the work order and enter this information into the MMIS system. See
Annex D for an example of work order form.
7.5 Biomedical Engineering Services shall document the parts needed on the work order.
7.6 Biomedical Engineering Services shall establish a method to monitor the status of work
orders awaiting parts. The equipment shall be tagged to indicate the serviceability and
facilitate traceability. An example of the tag is shown in Annex B.
7.7 Biomedical Engineering Services shall initiate the appropriate request for contract
services if the equipment requires contract, warranty, or third party repair service.
7.8 After completing any unscheduled maintenance, Biomedical Engineering Services shall
perform safety test in accordance with MS IEC 62353, performance and calibration check of
the equipment.
7.9 Biomedical Engineering Services shall perform an electrical safety test, if the
unscheduled maintenance involves replacement of defective electrical components or
dismantling of equipment before releasing the equipment to the user.
7.10 The Biomedical Engineering Services shall brief the user on work carried out upon
completion of repair prior to acceptance by the user. Both parties shall sign the work order to
verify the completion of work.
7.11 The Biomedical Engineering Services shall file the work order sheet to ensure
traceability.
The defect in the operations or usage of equipment detected by the user or staff of
Biomedical Engineering Services during operation or scheduled maintenance.
The defect in the operation or the usage of equipment is detected by user who takes the
equipment out of service. The user shall initiate a request for maintenance.
7.12.3.1 Emergency maintenance services shall be made available at all times to cater for
emergency breakdowns. Maintenance staff list and contact information shall be made
available to the users.
7.12.3.4 In the event that an emergency maintenance cannot be successfully done to the
equipment within the required time, the user shall be informed such that alternative measures
can be taken by the user to minimise clinical service disruption.
8. Acceptance testing
Acceptance testing shall be carried out for all newly introduced (new or used) equipment
before it is placed into clinical service and shall include visual inspection, electrical safety test
and performance test.
8.1 The user shall notify Biomedical Engineering Services on the arrival of new equipment.
8.2 The user shall ensure that the correct item(s) are delivered in good condition based on
the purchase document. The supplier shall provide a copy of the purchase document to the
Biomedical Engineering Services during or prior to the acceptance testing.
8.3 The supplier shall declare the manufacturing date, and the date of the first release of the
model into market.
8.4 The supplier shall carry out acceptance testing in the presence of Biomedical
Engineering Services and the user. The results of the acceptance testing shall be verified by
the Biomedical Engineering Services. Results shall be documented and handed over together
with all relevant certificates to the Biomedical Engineering Services.
8.5 When a contractor installation is required, Biomedical Engineering Services shall verify
correct installation is done based on the required specification.
8.6 Biomedical Engineering Services shall review the relevant contracts and literature for
warranty provisions, and advice the user to complete the warranty registration data, if
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
8.7 Biomedical Engineering Services shall give unique identification for newly introduced
equipment. The equipment shall be registered into a master list.
8.8 The supplier shall provide complete copies of the following items to Biomedical
Engineering Services:
a) user manual;
d) parts list;
8.9 The supplier shall provide a list of required test equipment and special tools to
Biomedical Engineering Services.
8.10 The user should ensure that initial inspection and acceptance test have been
conducted on leased, loaned, consigned, or privately owned equipment to be used within
healthcare facility.
8.11 If rectifications on the equipment are required to pass the acceptance test, the
rectifications shall be carried out by the supplier or relevant parties and the equipment shall
be subjected to acceptance test again.
8.12 Biomedical Engineering Services shall monitor the warranty period of the equipment.
Biomedical Engineering Services shall review health alerts, equipment failures, incident
reports, use errors, component failures and carry out corrective action.
9.1 Prepare, review and adjust preventive maintenance program and periodically assess
the effectiveness of the program.
9.2 Perform equipment audit (when necessary), document review and advise users on
proper handling during inspection visits.
9.5 Provide training for user and Biomedical Engineering Services personnel to reduce
hazards and to avoid potential risk/incident. Such training shall exclude clinical application.
9.8 Provide effective and responsive equipment repair including on-call services.
9.11 Annual evaluation report shall include equipment failures statistics and
recommendation.
10. Uptime
Achieve uptime targets as specified in Biomedical Engineering Services KPI for all equipment
in service.
10.1 Biomedical Engineering Services shall identify applicable uptime target for the
equipment with reference to KPI. A list of recommended uptime target is as per Annex E.
Uptime calculation is as per Annex F.
10.2 Biomedical Engineering Services shall record applicable uptime target in equipment
register.
10.3 Biomedical Engineering Services shall administer and monitor equipment compliance
with uptime targets.
10.5 Biomedical Engineering Services shall produce reports on uptimes for all equipment
on a periodic basis for review.
11.1 Biomedical Engineering Services shall identify the KPI of the services and set
appropriate standards to be achieved. Example of the indicators are as follows:
11.3 KPI shall be agreed by the healthcare facility authority and Biomedical Engineering
Services.
a) Structure
The Biomedical Engineering Services shall define the structure in which the QAP will
work in terms of:
i) physical setting;
b) Processes
i) identification of problem;
c) Outcome
11.5 The healthcare facility authority shall review the QAP proposed by the Biomedical
Engineering Services and comment accordingly.
11.6 Biomedical Engineering Services shall provide healthcare facility authority the agreed
information and maintain accurate records, procedures and other documents in the QAP. The
data collected shall be analysed for further improvement of the structure and processes.
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
12.1 Biomedical Engineering Services shall progressively develop and apply MMIS.
12.2 Biomedical Engineering Services shall train all relevant parties to use MMIS.
12.4 The MMIS should consist, but not limited to, the following modules and be accessible
to authorised users:
12.8 Healthcare facilities without Biomedical Engineering Services shall maintain a manual
maintenance management system.
13.1 The warranty provider shall provide PPM schedule and warranty register shall be
updated and maintained accordingly by Biomedical Engineering Services.
13.3 PPM covered under the warranty provisions shall be monitored accordingly and
notification shall be given to warranty provider to comply with warranty provisions. The user
shall be informed if warranty provider fails to comply with warranty provisions.
13.4 PPM and corrective maintenance carried out by warranty provider shall be supervised
and monitored. The details of maintenance work carried out by the warranty provider or its
appointed party shall be recorded accordingly.
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
13.5 The warranty provider shall be responsible to ensure the medical device is in good
working condition upon warranty expiry. Any fault reported during warranty period shall be
rectified by the warranty provider or any party appointed by the warranty provider.
13.6 The user department shall inform the Biomedical Engineering Services at least 30
days prior to warranty expiry of any faults of the device that require rectification by the
warranty provider.
Decommissioned equipment is medical equipment that has been taken out of service pending
disposal.
14.1 The user shall provide notification and the list of decommissioned equipment to the
Biomedical Engineering Services and asset register shall be updated accordingly.
14.2 Biomedical Engineering Services and user shall ensure all equipment is safe for
disposal.
14.3 Any ionising radiation equipment shall be decommissioned as per the Atomic Energy
Licensing Act 304.
14.4 Biomedical Engineering Services shall remove all decommissioned equipment from
use. All decommissioned equipment shall be placed into a designated area.
16.1.1 The user shall decontaminate any equipment such as aspirators, dialysis related
equipment, surgical related equipment, laboratory equipment, or any equipment suspected to
be hazardous or being contaminated prior to any maintenance activity.
16.1.2 The user shall declare in the maintenance request that the decontamination has been
performed.
16.1.3 The decontamination process shall follow established procedures and be carried
out by trained personnel.
16.1.4 Biomedical Engineering Services shall identify and set their own KPI for these
activities. For examples of KPI in all government hospitals and institutions please refer to
Annex H.
17.1 The user shall report immediately all incidents related to medical equipment to the
safety officer and Biomedical Engineering Services and prepare a written report within 24
hours.
17.2 Respective equipment, its accessories and consumables shall be taken out of use,
tagged and stored in a secured area.
17.3 All incidents involving the failure of equipment shall be investigated and all parties
including Biomedical Engineering Services shall cooperate fully with the investigating body.
17.4 Biomedical Engineering Services shall manage equipment hazard alerts and recall
notices provided by equipment suppliers and/or established organisations as per the
following:
a) Biomedical Engineering Services shall check equipment register for equipment items
identified in hazard alerts and recall notices;
b) Biomedical Engineering Services shall disseminate hazard alert and recall notices to
relevant user and take appropriate action to eliminate identified hazards; and
c) Biomedical Engineering Services shall take appropriate action to arrange for recall of
items as required.
17.5 In the event of an incident that involve the same model of equipment in any country or
location, the manufacturer or supplier shall inform the healthcare facility authority, user and
Biomedical Engineering Services and take corrective action to ensure the equipment is safe
to use.
18.1 Biomedical Engineering Services shall offer or coordinate training when a new
equipment system is first issued and periodically as requested.
18.2 When the need arises, either requested or planned, Biomedical Engineering Services
shall provide or coordinate training to users to cover among others the following:
c) user maintenance;
18.3 Biomedical Engineering Services and users shall maintain training records.
18.4 Biomedical Engineering Services shall periodically analyse the maintenance record to
see the need for further user training. Biomedical Engineering Services who see such
problems should document the discrepancies, and offer user training to the relevant user
department and equipment users.
18.5 Biomedical Engineering Services, the manufacturer, qualified third parties, or medical
staff members can provide user training.
18.6 When procuring new equipment, healthcare facility authority shall include a
requirement in the contract that the manufacturer or its representative shall provide training
for both Biomedical Engineering Services and users.
19.1 Biomedical Engineering Services shall survey all equipment and identify required
spare parts.
19.2 Biomedical Engineering Services shall source required genuine or equivalent spare
parts.
19.3 Biomedical Engineering Services shall recommend with supporting document to the
healthcare facility authority or appointed authority on the use of equivalent genuine or original
equipment manufacturer (OEM) spare parts authorisation.
19.4 Biomedical Engineering Services shall report to the healthcare facility authority or
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
appointed authority in the event that the manufacturers do not assist in providing supporting
document.
19.5 Biomedical Engineering Services shall maintain adequate stock of required genuine
spare parts and practice good store management.
b) drawings;
c) software;
21.1 Healthcare facility authority shall determine the requirement for establishing a
Biomedical Engineering Services workshop.
21.2 In the event that a workshop is required, healthcare facility authority shall set up the
workshop based on the size of the healthcare institution and the healthcare services available
in the institution.
21.3 The workshop area shall be adequate in size (preferably 120 ft2 to 150 ft2 if
documentation storage and parts storage is included into the immediate work area for every
personnel). Refer Annex J for examples of workshop setup. Figure J1 indicates layout for a
maximum of two personnel and Figure J2 indicates layout for a maximum of 6 personnel.
21.4 The workshop should be equipped with proper tools, and test equipment inventory
(refer to Table 1 for lists of common test equipment that may be needed); and personal
protective equipment (PPE) to perform the maintenance services.
21.5 Biomedical Engineering Services workshop may consist of the followings, where
applicable:
b) Equipment storage area: secure area to store equipment awaiting parts or maintenance
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
c) Repair parts storage area: secure area to properly store repair parts.
d) Administrative area: a well-lit area for administrative functions and customer service
(preferably one administration workstation for every two maintenance personnel).
e) General work area: a well-lit area for technician workbenches (preferably one workbench
for every maintenance personnel).
f) Proper mercury handling facility and procedure shall be established where applicable and
in compliance with relevant regulations.
g) Equipment maintenance facility requirements may include multiple 240 V outlets and at
least one each 415 V, 60 A single and three-phase AC power outlet. Requirements also
include earth leakage circuit breaker (ELCB), telephone service, emergency eyewash,
internet and LAN connectivity, medical air, nitrous oxide and scavenging system (if it has
analgesia or anaesthetic devices), vacuum system, ventilation and temperature control,
and wash sink.
21.6 Keep the maintenance area clean and orderly. Equipment and work surfaces should be
cleaned, waste removed and disposed off properly on a regular basis.
21.7 Ensure work flow and status of pending repair works are clearly indicated and
recorded.
21.8 Accessibility
21.8.1 Locate the workshop facility where equipment can be brought in without
unnecessary handling and exposure to bad weather.
21.8.2 Preferably the workshop shall be in the proximity of the critical clinical area of the
healthcare facility.
21.9 Facilities for proper cleaning of equipment and hand washing shall be provided to
prevent unnecessary exposure of potential hazard and infectious agents.
21.10 Ventilation in the work area shall comply with regulatory requirements related to the
adequate dissipation of vapours associated with chemicals (fluids, agents, substances,
compounds, etc.) that are used in the work area.
21.11 All recommended requirement are applicable to any party involved in carrying out
Biomedical Engineering maintenance.
Type Equipment
General Function Generator
Electrical Safety Analysers
Oscilloscopes
Digital Multimetres
Pressure Gauges
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
Digital Tachometer
DC Power Supply
Patient Simulator
Calibrated Weights
Digital Thermometer
Digital Luxmeter
Specialty Ventilator Analyser
Electrosugical Unit Analyser
Defibrillator Analyser
Radiation Detector / Survey Meter
Infusion Pump Analyser
kVp Meter
Collimator test tool
a) selection of equipment;
b) equipment installation;
d) replacement of equipment;
g) disposal.
Equipment may be proposed for removal from operation when it satisfies one or more of the
followings:
ii) accumulated maintenance cost plus the estimated cost of impending upcoming
repairs exceeds the depreciated value of the equipment;
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
b) worn out - when the equipment would not function properly even though repairs are
carried out;
c) unreliable - when it is not meeting up to its acceptable level of performance for its
intended use;
i) a new model of the same equipment has a design change resulting in a better
efficiency and increased capacity;
ii) a new concept for the service provided by the equipment is introduced;
h) possible benefits of new model (features, usability, more clinically effective, lower running
costs); or
22.2 Recall
Upon receiving recall notice, Biomedical Engineering Services shall advise the user and take
appropriate action to the affected equipment. The equipment shall be isolated from use and
tagged with appropriate label.
22.3 Upon request, Biomedical Engineering Services shall provide updated information
regarding latest technology to user department. This information shall assist user for
equipment procurement program.
22.4 As and when required, Biomedical Engineering Services shall provide advice to user
department on equipment replacement plan.
Policies should include the need to establish advisory groups to ensure the procurement
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
requirements take into account the needs of all parties involved in the use, commissioning,
decontamination, maintenance and decommissioning of medical equipment.
23.1 Biomedical Engineering Services shall provide advice upon request by healthcare
facility authority prior to procurement, such as:
23.2 All equipment supplied to the healthcare facility shall conform to relevant
international/national electrical safety standard; i.e. MS IEC 60601-1 for medical electrical
equipment and MS IEC 61010-1 for laboratory equipment; and relevant product standards.
23.3 The medical equipment to be procured shall comply with Malaysian power supply rating
of 240 V with a tolerance of +10 % -5 %, 50 Hz (single phase) and 415 V with a tolerance of
+10 % -5 %, 50 Hz (three-phase).
23.4 The condition for purchase shall include provision for future modification of equipment
and provision for software upgrades.
23.5 The criteria for selection shall be based on efficacy, effectiveness, performance, safety,
reliability, features, ease of use, cost-effectiveness, service, training and continuous support
for the user and equipment maintenance.
23.6 Supplier shall provide complete copies of the following items to the healthcare facility
authority and Biomedical Engineering Services:
a) user manual;
e) parts list;
23.7 Supplier shall provide complete technical training to the Biomedical Engineering
Services and user training.
23.8 Final payment shall be paid to the supplier upon meeting the terms and conditions of
contract/purchase order and clearance from Biomedical Engineering Services.
Annex A
(normative)
A1. Introduction
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
c) an examination.
MS 2058:2009
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
a
Area of specialisation to be declared based on specific model of medical devices.
b
For Level 3 competency, the person is given an option to expand their specialisation level based on their training advancement and experiences.
c
For Level 4 competency, the person at vendor and manufacturer are given an option to exclude the lower specialisation level.
d
For management level, the manager is required to obtain a minimum competency on general/basic level medical device specialisation.
e
The sample of medical devices specialisation are given in Tables A2 to A5 and subject to changes based on its complexity and cost of the equipment.
MS 2058:2009
31
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
32
MS 2058:2009
Table A2. Radiology and imaging equipment specialisation classification (sample)*
Mixers, X-ray film chemistry Radiographic systems, film Injectors, contrast media, magnetic resonance imaging
MS 2058:2009
Incinerators, pathology
Incubators, laboratory
Insufflators
Keratomes
33
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
34
MS 2058:2009
Table A3. Laboratory equipment specialisation classification (sample)* (continued)
Stirrers
Synoptophores
Timers, coagulation
Ureterotomes
Washer
Water bath circulators
Water purification systems, ultraviolet
* Subject to changes based on its complexity and cost.
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
MS 2058:2009
Electroretinographs Uterine activity monitors
EMG monitors, telemetric Urodynamic measurement systems
Eye movement monitors Spirometres
Fetal heart detectors Plethysmographs
35
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
36
MS 2058:2009
Table A4. Diagnostic equipment specialisation classification (sample)* (continued)
Prism bars
Projectors, cine
Recorders
Retinoscopes
Scales
Scanners, long term recording, ECG
Sphygmomanometres, aneroid
Sphygmomanometres, electronic
Sphygmomanometres,mercury
Television monitors
Testers, pulp
Thermometres
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
MS 2058:2009
37
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
38
MS 2058:2009
Table A5. Therapeutic equipment specialisation classification (sample)*
Compression unit, sequential Defibrillator Microwave therapy system, tissue ablation, endometrial
Counters, intravenous drop Dermatoscopes Stimulators, electrical, brain, convulsive therapy
Crimpers Dialyzer reprocessing units Thyroid uptake systems
Ultrasound therapy/neuromuscular stimulation systems,
Dental delivery units Duodenoscopes
physical therapy
Dental engines Ear/nose/throat treatment units
Dental hand instruments, surgical Electrosurgical units
Dermatomes Gastroscopes
Desensitizers Gonioscopes
Drills Heart-lung bypass units
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
MS 2058:2009
Lights Television systems, endoscope
Loupes Tonometres, ophthalmic
Magnets, eye Ultrasonic surgical unit
39
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
40
MS 2058:2009
Table A5. Therapeutic equipment specialisation classification (sample)* (continued)
Slit lamps
Stimulators, caloric, physical therapy, fluidised
medium
Tables, examination/treatment
Tables, operating
Tourniquets, pneumatic
Tracheal tube introducers
Traction units
Training manikins, cardiopulmonary resuscitation
Transilluminators
Trimmers. Model, dental
Ultrasonic cleaning system
Vacuum extractors, obstetrical
Vacuum-mixing devices, dental
Vibrators
Warming units
Water purification systems
Welding units, orthodontic
Wire drivers
Apheresis units
MS 2058:2009
41
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
42
MS 2058:2009
Table A6. Biomedical Engineering maintenance competency levels and skills matrix
Competency levels
Skills
Level 1 Level 2 Level 3 Specialist Management
Understanding of the anatomy, physiologic and biomedical equipment classification for specific medical √ √ √ √ √
Theory
device (refer to table A2 to A5).
√ √ √ √ √
Be able to perform an effective electrical safety procedure on the specific medical device.
Safety
√ √ √ √ √
Understanding of test fixtures and test equipment specific to the medical device.
Understanding of manufacturer Planned Preventive Maintenance (PPM) procedures and follows √ √ √ √ √
appropriate steps to complete the task for specific medical devices.
Servicing
√ √ √ √ √
Be able to perform an effective performance testing and calibration on the specific medical device.
First line repair: Be able to identify and perform breakdown and corrective maintenance of the medical √ √ √ √ √
devices at the point of care.
© STANDARDS MALAYSIA 2009 - All rights reserved
Second line repair: Be able to identify intermediate corrective actions required for the corrective √ √ √
maintenance of the specific medical device up to module/board levels at maintenance workshop either - optional
Repair
internal or external.
Third line repair: Be able to identify advance corrective actions required for the breakdown maintenance √ √
of the specific medical device up to component levels and complete overhaul at specialised or - - optional
manufacturer facilities.
Be able to complete accurately the necessary Biomedical Engineering related documentation. √ √ √ √ √
√ √ √
2 Equipment resetting and general checking
√ √ √
3 Common repair such as replacement of light bulbs, batteries, probes, electrode, tubing, and equipment consumables.
√ √ √
4 Troubleshoot and repair minor defect related to power supply.
√ √ √
5 Spare parts identifications
√ √
6 Repair and replacement of equipment modules, assemblies or boards (PCB)
√ √
7 Ensure equipment requiring calibration is calibrated before use on a patient.
√ √
8 Repair and replacement of component or subcomponent of the equipment PCB
√
9 Performing complex maintenance tasks that call for special skills, tools, or equipment
√
10 Software re-programming of medical device
√
11 Performing specialized calibration on medical device
√
12 Modification and upgrading of medical device system & software.
√
13 Total overhaul or refurbishment of medical device
NOTE. Refer to Table A1 to A5 for specific medical device except for first line breakdown maintenance levels.
MS 2058:2009
43
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
44
MS 2058:2009
Table A8. Management skills level matrix
Management levels
Management skills
Management 1 Management 2 Management 3
4 Communication skills √ √ √
Service management: To provide organisation with vision, leadership and resources to achieve planned service √
13 - -
goals and objectives.
1 2 3
Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Degree in Biomedical Passed Passed 3 B and Any 3 5
1 6 mth 1 year C1, C2, with
Engineering A A and B years of C1, C2, years years
C3 or C4 Relevant
C3 or C4 4
or D Mgmt
Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Degree in Electronic Passed Passed 3 B and Any 3 5
2 9 mth 2 years C1, C2, with
Engineering A A and B years of C1, C2, years years
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Degree in other relevant Passed Passed 5 B and Any 3 5
3 1 year 3 years C1, C2, with
engineering A A and B years of C1, C2, years years
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Diploma in Biomedical Passed Passed 7 B and Any 3 10
4 1 year 5 years C1, C2, with
Engineering A A and B years of C1, C2, years years
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
√ √ √ √ √
MS 2058:2009
Passed
Passed A and/or
Passed A,
Any of B, C, D
Diploma in Electronic Passed Passed 7 B and Any 3 10
5 1 year 5 years C1, C2, with
Engineering A A and B years of C1, C2, years years
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
45
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
46
MS 2058:2009
Table A9. Biomedical Engineering career development matrix (continued)
1 2 3
Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert
Passed
Passed A and/or
Passed A ,
Diploma in other Any of B, C, D
Passed Passed 7 B and Any 10 10
6 relevant engineering X 2 years X 5 years X X C1, C2, X with
A A and B years of C1, C2, years years
field C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
Certificate in
Passed Passed
7 Biomedical X 1 year X 7 years
A A and B
Engineering
Certificate in
Passed Passed
8 Electronic X 1 year X 7 years
A A and B
Engineering
Certificate in other
Passed Passed
© STANDARDS MALAYSIA 2009 - All rights reserved
Passed 10 Passed
10 Lower qualifications X 2 years X
A years A and B
1
This means “qualification”.
2
This means “experience”.
3
This means “certificate”.
4
This means “management”.
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
Biomedical Equipment Specialisation Maintenance Certification in Radiology (Ionizing & Non-Ionizing) &
C1 Imaging medical devices. Provided by competent certifying body recognised by MOH. (Certificate of
Competency Biomedical Engineering Maintenance Level 3 - Radiology and Imaging)
MS 2058:2009
medical devices. Provided by equipment manufacturer and endorsed by competent certifying body
D
recognised by MOH. [Certificate of Competency Biomedical Engineering Maintenance Level 4 (by Medical
Device Model)]
47
MS 2058:2009
Annex B
(informative)
PPM
Date Next Due Date*
Done By
Commissioning Date
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
PPM Frequency
Proposal Reference No
Submission Date
Decommissioning Cert. No
DANGER !
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
EQUIPMENT IS OUT
OF ORDER
EQUIPMENT
UNDER
OBSERVATION
DO NOT USE ON
PATIENT
From: …….(date, time)
To: ………. (date, time)
Annex C
(informative)
CHECKLIST NO:
KEMENTERIAN KESIHATAN MALAYSIA 16231-003
BEMS Planned Preventive Maintenance Checklist
Electrocardiographs, Multichannel, Interpretative
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
PPM YTD : ( 1 / 1 )
TYPE CODE : 16-231
If there is evidence of body fluid contamination, submit the device for cleaning and decontamination before inspecting it.
Wear appropriate Personnel Protection Equipment (PPE) during work.
Wear grounded electrostatic wristband when handling PCB or electronic components.
Refer to the safety procedure for additional precautions and guidance as per manufacturer guidelines.
Make sure the test equipment used are duly calibrated.
ECG SIMULATOR
________________________________
________________________________
________________________________
Notes:
*For all parts, NA is defined as NOT APPLICABLE
**If you have ticked 'NOT DONE', then justify in Part 8
CHECKLIST NO:
KEMENTERIAN KESIHATAN MALAYSIA 16231-003
BEMS Planned Preventive Maintenance Checklist
Electrocardiographs, Multichannel, Interpretative PPM YTD : ( 1 / 1 )
TYPE CODE : 16-231
WORK ORDER NO
mm/sec 50 48 - 52 ( ) ( ) ( )
bpm 80 78 - 82 ( ) ( ) ( )
CHECKLIST NO:
KEMENTERIAN KESIHATAN MALAYSIA 16231-003
BEMS Planned Preventive Maintenance Checklist
Electrocardiographs, Multichannel, Interpretative PPM YTD : ( 1 / 1 )
TYPE CODE : 16-231
WORK ORDER NO
PASS FAIL NA
PART 8 NOTES
Part 6, Item 1
By using an ECG simulator, supply of 60 bpm ECG to the unit and tracing set to 25mm/sec and 50mm/sec, the disctance between the peak to peak should
be 25mm and 50mm respectively or within the tolerance limit.
Reference:
MAC 1200/MAC 1200 ST service manual
PPM has been performed in accordance to the checklist and the equipment is functioning to the intended purpose.
COMPLETED BY :
DATE :
54
MS 2058:2009
Annex D
(informative)
Annex E
(informative)
hours 5 to 10
(Days) 5 years
years
Aneasthesia units and vaporisers C 24 7 99 % 95 %
Aneasthesia ventilator C 24 7 99 % 95 %
Aspirators C 24 7 99 % 95 %
Alternating pressure mattress P 12 6 96 % 92 %
Defibrillators C 24 7 99 % 95 %
Diathermy unit C 24 7 99 % 95 %
Dental Equipment P 24 7 96 % 92 %
Electrosurgical units C 24 7 99 % 95 %
Heamodialysis units C 24 7 99 % 95 %
Humidifiers C 24 7 99 % 95 %
Hypo/hyperthermia units C 24 7 99 % 95 %
Incubators C 24 7 99 % 95 %
Infusion controllers/pumps C 24 7 99 % 95 %
Lasers C 24 7 99 % 95 %
Lithotripters C 12 6 99 % 95 %
Pacemakers C 24 7 99 % 95 %
Peritoneal dialysis unit C 24 7 99 % 95 %
Phototheraphy units C 24 7 99 % 95 %
Radiant warmers P 24 7 96 % 92 %
Radiographic dye injection C 24 7 99 % 95 %
Resuscitators C 24 7 99 % 95 %
Radiotheraphy equipments P 12 6 96 % 92 %
Surgical drills and saws C 24 7 99 % 95 %
Stimulators P 12 6 96 % 92 %
Surgical tables C 24 7 99 % 95 %
Traction units P 12 6 96 % 92 %
Ventilators C 24 7 99 % 95 %
Ultrasonic nebulizers P 12 7 96 % 92 %
Ultrasonic therapy P 12 6 96 % 92 %
Uptime
Operating Uptime
Operating Equipment
2. Diagnostic equipments Group hours/week Equipment
hours 5 to10
(Days) < 5 years
years
Apnoea monitors C 24 7 99 % 95 %
Ambulatory ECG recorded and scanners P 24 7 96 % 92 %
Blood pressure units (non invasive
C 12 6 96 % 92 %
inversive electronic units)
Capnographs C 24 7 99 % 95 %
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
Uptime
Operating Uptime
Operating Equipment
3. Laboratory Equipments Group hours/week Equipment
hours 5 to10
(Days) < 5 years
years
Analysers P 12 6 96 % 92 %
Amino acid P 12 6 96 % 92 %
Bilirubinometres P 12 6 96 % 92 %
Blood gas P 12 6 96 % 92 %
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
Calcium P 12 6 96 % 92 %
Clinical chemistry P 12 6 96 % 92 %
Coagulation P 12 6 96 % 92 %
Counter, gamma P 12 6 96 % 92 %
Electrolyte P 12 6 96 % 92 %
Immunoassay P 12 6 96 % 92 %
Glucose P 12 6 96 % 92 %
Heamatology P 12 6 96 % 92 %
Platelet aggregation P 12 6 96 % 92 %
Spectrophotometres P 12 6 96 % 92 %
Atomic absorption P 12 6 96 % 92 %
Atomic absorption units P 12 6 96 % 92 %
Automatic blood grouping systems P 12 6 96 % 92 %
Automatic microbiological systems P 12 6 96 % 92 %
Blood bank centrifuges P 12 6 96 % 92 %
Centrifuges P 12 6 96 % 92 %
Cytometres P 12 6 96 % 92 %
Chromatographs gas/liquid P 12 6 96 % 92 %
Electrophonesis equipment P 12 6 96 % 92 %
Flame photometres P 12 6 96 % 92 %
Microscopes P 12 6 96 % 92 %
pH metres P 12 6 96 % 92 %
NOTE. Operating hours and operating days are indicative only. Medical services at healthcare institutions are
provided at all times and the equipments may be used/operated at any time of the day or available for use at
any time.
Annex F
(normative)
Calculation of uptime
TIME
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
MAINTENANCE
DELAY TIME
TIME
UPTIME
UPTIME TARGET = x 100 %
UPTIME + DOWNTIME
where,
DOWNTIME is the time the equipment is unavailable for clinical use due to failure or out
of calibration.
NOTES:
1. Upgrading time is time during which equipment is undergoing upgrading or replacement or when the equipment
is out of service for renovations or upgrading.
2. For equipments that are required only during normal office working hours, the Uptime Targets shall be based on
a maximum uptime of 2 340 h (i.e. 52 weeks X 45 h/week) per year.
3. For equipments that are required 24 hr everyday the Uptime Targets shall be based on a maximum uptime of
8 760 h (i.e. 365 days X 24 h/day) per year.
4. For other requirements the maximum uptime per year shall be determined based on the same principle
Annex G
(informative)
− Asset description
− Department
− Section/division
− Location code
− Location description
− Category
− Type
− Brand & model
− Manufacturers serial no.
− Cost
− Date received/purchased
− Supplier name
− File reference number
− Accessories
− Signature of responsible officer
− Date of signature
− Location
− Location changed to
− Date of location change
− Signature of location change
− Checked
− Date checked
− Signature for checking
− Number of
− Description
− Quantity
− Manufacturer
− Service agent
− Responsibility
− Area/department serviced
− Warranty start date
− Warranty completion date
− Commissioning parameters
− Membership of functional group
− Functional group dependant
− Registration certificate number
− Disposal reference
− Date disposed
− Signature for disposal
− Notes
− Service history
− Asset number
− Works requested
− Works request received by name
− Works request received by date
− Works request received by time
− Works request completion verification by name
− Works request completion verification by date
− Works request completion verification by time
− Works request assessment cause code
− Works request assessment by name
− Works request assessment by date
− Works request assessment by time
− Works request type code
− Parts required
− Access restrictions
− Safety instructions
− Estimated hours
− Schedule interval
− Schedule start date
− Contractor
Annex H
(informative)
e) 24 h on-call basis.
h) Compliance to guidelines on
Biomedical Engineering
maintenance competency and
career development.
8. To cooperate in the Produce report on the status of the Number of reported equipment
investigation of related maintenance history of the equipment related incident.
incidents
9. To train users on daily Identify the need for training on specific Number of user training conducted.
user maintenance procedure equipment and action taken.
(excludes clinical procedure
related to the equipment)
10. To maintain a stock of a) To assist in maintaining the uptime Availability of critical and
genuine spares. targets. recommended spares.
b) Adequate supplies of maintenance
kits.
11. Establish a library of user All equipment engineering workshop shall Number of service manuals not
and service manuals. have a documented list of service available for critical care
manuals. equipments.
Annex J
(informative)
3' - 0"
Parts/ Equipment
2' - 0"
Cleaning Area
consumables Storage
storage
5' - 0"
1' - 6"
File
3' - 0"
rack
Referances/
manuals
Rack
10' - 0"
Admin workstation
5' - 0"
Workbench
Dimensions in feet
8’ 16'
2’
14’
Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking prohibited
4’ Storage Cabinet
6’
O
R
24’
K
B Storage
Cabinet
20’
E
N
LOCKER
17’ C
H Solder
5’
Station
Electronic 4’
Component
8’
9’
Ready Equipment SINK
16’
P.P.E Area Shower
9’
Toilet
Fume Hood
Cabinet
5’ 13’ 5’ 6’
29’