..Members Only
Welcome to ISC on Medical Devices and Facilities for Healthcare
Scope
Standardisation of: • medical devices, covering the whole life cycle such as design, development, manufacture, pre-market, placement on market, post market, use, operation and maintenance and disposal; and • facilities for healthcare, covering the design and application aspects for healthcare facilities.
Chairman
Mr Zamane Abdul Rahman
Medical Device Bureau
Ministry of Health Malaysia
5th Floor, Boulevard Plot 3C4, No 26, Jalan Persiaran Perdana, Presint 3
62675, Putrajaya
WP PUTRAJAYA
Tel : 0388850778
Fax : 0388850758
Email : zamane@mdb.gov.my

Secretary
Salbiah Yaakop
SIRIM Berhad
1, Persiaran Dato' Menteri
P.O. Box 7035, Section 2
40911 Shah Alam
SELANGOR
Tel : 03-5544 5680
Fax : 03-5510 6389
Email : salbiah@sirim.my

List of Malaysian Standards Published under Medical Devices and Facilities for Healthcare : 195

Progress Report of the Technical Committee / Working Group under ISC on Medical Devices and Facilities for Healthcare as at

Member's Organisation
Atomic Energy Licensing Board
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 Organisation of Pharmaceutical Industries
Malaysian Rubber Board
Malaysian Rubber Export Promotion Council
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
Universiti Teknologi Malaysia

List of Technical Committees (TC) / Working Groups (WG) under Medical Devices and Facilities for Healthcare
Quality Management and Corresponding General Aspects for Medical Devices(TC/R/1)
Disposable Single Use Devices(TC/R/2)
Anaesthetic/Respiratory and Electromechanical Devices(TC/R/3)
Diagnostic and Therapeutic Radiation(TC/R/5)
Implants for Surgery(TC/R/6)
Clinical Laboratory Testing and In Vitro Diagnostic Test Systems(TC/R/7)
Non systemic contraceptives and STI barrier prophylactics(TC/R/8)
Ophthalmic Optics(TC/R/9)
Code of Practice of Active Medical Devices and Low-Voltage Electrical Equipment/System for Healthcare Facilities(TC/R/10)