MS 2058:2009

CODE OF PRACTICE FOR GOOD ENGINEERING MAINTENANCE MANAGEMENT OF ACTIVE MEDICAL DEVICES (FIRST REVISION) ICS: 11.040.01 Descriptors: medical electrical equipment, code of practice, Biomedical Engineering, maintenance,

services, active medical device

Copyright 2009 DEPARTMENT OF STANDARDS MALAYSIA

MALAYSIAN STANDARD

DEVELOPMENT OF MALAYSIAN STANDARDS

The Department of Standards Malaysia (STANDARDS MALAYSIA) is the national standardisation and accreditation body.

The main function of the Department is to foster and promote standards,

standardisation and accreditation as a means of advancing the national economy,

promoting industrial efficiency and development, benefiting the health and safety of

the public, protecting the consumers, facilitating domestic and international trade and

furthering international cooperation in relation to standards and standardisation.

Malaysian Standards are developed through consensus by committees which

comprise of balanced representation of producers, users, consumers and others with

relevant interests, as may be appropriate to the subject in hand. To the greatest

extent possible, Malaysian Standards are aligned to or are adoption of international

standards. Approval of a standard as a Malaysian Standard is governed by the

Standards of Malaysia Act 1996 (Act 549). Malaysian Standards are reviewed

periodically. The use of Malaysian Standards is voluntary except in so far as they are

made mandatory by regulatory authorities by means of regulations, local by-laws or

any other similar ways.

The Department of Standards appoints SIRIM Berhad as the agent to develop Malaysian Standards. The Department also appoints SIRIM Berhad as the agent for

distribution and sale of Malaysian Standards.

For further information on Malaysian Standards, please contact: Department of Standards Malaysia OR SIRIM Berhad Century Square, Level 1 & 2 (Company No. 367474 - V) Block 2300, Jalan Usahawan 1, Persiaran Dato Menteri 63000 Cyberjaya P.O. Box 7035, Section 2 Selangor D.E. 40911 Shah Alam MALAYSIA Selangor D.E. Tel: 60 3 8318 0002 Tel: 60 3 5544 6000 Fax: 60 3 8318 1455 Fax: 60 3 5510 8095 http://www.standardsmalaysia.gov.my http://www.sirim.my E-mail: central@standardsmalaysia.gov.my

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STANDARDS MALAYSIA 2009 - All rights reserved i

CONTENTS

Page Committee representation ........... iii Foreword ................ iv 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 1 List of common test equipment.. 24 A1 Competency levels and device specialisation classification matrix . 31 A2 Radiology and imaging equipment specialisation classification (sample) 32 A3 Laboratory equipment specialisation classification (sample). 33 A4 Diagnostic equipment specialisation classification (sample). 35 A5 Therapeutic equipment specialisation classification (sample) ..... 38 A6 Biomedical Engineering maintenance competency levels and skills matrix 42 A7 Biomedical Engineering breakdown maintenance levels 43 A8 Management skills level matrix 44 A9 Biomedical Engineering career development matrix 45

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ii STANDARDS MALAYSIA 2009 - All rights reserved

CONTENTS (continued)

Page Figures 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 A Biomedical Engineering competency and career development guidelines . 28 B Examples of equipment tags . 48 C Example of PPM checklist based on manufacturers service manual. 51 D Example of work order form... 54 E Recommended uptime target for equipment... 55 F Calculation of uptime ...... 58 G MMIS for Biomedical Engineering Services 59 H Key performance indicator (KPI) .. 63 J Example of workshop setup 65

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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: Association of Malaysian Medical Industries Association of Private Hospitals of Malaysia Atomic Energy Licensing Board Biomedical Engineering Association Malaysia Department of Standards Malaysia Federation of Malaysian Manufacturers Institute for Medical Research Malaysia Medical Device Association Malaysian Association of Standards Users Malaysian Medical Association Malaysian Nuclear Agency Malaysian Organization of Pharmaceutical Industry Malaysian Rubber Board Malaysian Rubber Export Promotion Council Medical Device Bureau Ministry of Health Malaysia Pharmaceutical Association of Malaysia Radiation Physics, Biophysics and Medical Physics Sub-Group of Institute of Physics Malaysia SIRIM QAS International Sdn Bhd Universiti Kebangsaan Malaysia (Faculty of Allied Health Sciences) Universiti Teknologi Malaysia (Faculty of Science) 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: Association of Private Hospitals of Malaysia Biomedical Engineering Association Malaysia Faber Medi-Serve Sdn Bhd/Healthtronics Malaysia Sdn Bhd Healthcare Technical Services Sdn Bhd (KPJ) Hospital Universiti Kebangsaan Malaysia Independent Expert Malaysian Medical Association Ministry of Health Malaysia (Medical Device Bureau) Ministry of Health Malaysia (Engineering Services Division) Pantai Medivest Sdn Bhd Radicare (M) Sdn Bhd SIRIM Berhad (Secretariat) Sistem Hospital Awasan Taraf Sdn Bhd Universiti Kebangsaan Malaysia (Faculty of Allied Health Sciences) Universiti Malaya (Department of Biomedical Engineering) Universiti Sains Malaysia (Medical Campus) Universiti Teknologi Malaysia (Faculty of Electrical Engineering) University Malaya Medical Centre

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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. This Malaysian Standard is the first revision of MS 2058, Code of Practice for Good Engineering Maintenance Management of Active Medical Devices. Major modifications in this revision are as follows: a) Incorporation of new definition on active medical device; b) the definition for breakdown maintenance was modified; c) amendment to the definition of emergency maintenance; d) incorporation of new definition on healthcare facility; e) incorporation of new definition on medical device; f) sub-clause 5.2 p) regular monitoring of hazards and alerts relating to medical devices,

was added; g) amendment to sub-clause 6.6.1 a); h) amendment to first paragraph of 6.7.1.2; i) amendment to sub-clause 21.5 g); j) amendment to first paragraph of 22.1; k) incorporation of sub-clause 22.1 g); l) amendment to sub-clause 23.1 f); m) amendment to sub-clause 23.3; n) incorporation of new Figure A1; o) amendment to examples of equipment tags in Annex B; p) amendment to PPM checklist examples in Annex C; and q) incorporation of new Figure J2, to give an example workshop setup for a maximum of

six personnel. This Malaysian Standard cancels and replaces MS 2058:2008. Compliance with a Malaysian Standard does not of itself confer immunity from legal obligations.