INGENIEUR
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Division , as shown in Figure 9 ) is defined within the milestone before the device delivery phase .
4 . MS 2739:2021 – Requirements for installation , testing and commissioning ( T & C ) and acceptance of medical device ( Code of Practice )
This Malaysian Standard ( MS ) applies to medical devices placed for use in any healthcare facility or any other facility or residential premises which require installation , testing and commissioning ( T & C ) and acceptance , excluding implantable medical devices . This standard is intended to :
● Provide guidance to comply with the requirements under Section 43 , Usage , operation and maintenance of medical device in the Medical Device Act 2012 ( Act 737 );
● Provide guidance on the procedures for the installation , T & C and acceptance of medical devices in any healthcare facility , aesthetic settings , and premises for wellness programs and related services ; and
● Ensure the medical device is appropriately installed , tested and commissioned by the equipment specialists or competent
personnel and accepted in accordance with the manufacturer ’ s specification , purchase agreement and statutory requirement .
5 . MS IEC 60601 and MS IEC 62353 on Electrical Safety Test ( EST )
Based on the typical life cycle of a medical device , the region of electrical safety test in T & C is specified as whether to utilise the MS IEC 60601 or MS IEC 62353 version . Figure 11 summarises the differences between them in terms of reference selection ;
6 . MS2058:2018 – Code of Practice for good engineering maintenance management of active medical devices ( Second Revision )
Please refer to Figure 12 : Area of MS2058:2018
Engineering administration and control
Given all of the legal conditions listed above , the supervision of project milestones is administered and controlled by an identified protocol as outlined
Requirement for installation
Site Preparation
Medical device installation
Calibration
Testing and comissioning
Inspection of nonactive medical device
Issuance of T & C Certificate
Training Acceptance
Figure 10 : The scope of MS 2739:2021
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