ingenieur Vol98 2024 | Page 49

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1 . Design ( R & D ) ✓ Subject to initial & clinical trials . ✓ Electronic & Mechanical design of the product must be in line with IEC 60601 .
5 . Maintenance ( Repair ) ✓ Referred as Re-Active Maintenance . ✓ Device create a fault OR require an upgrade , then it will susceptible to further inspections & testing .
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2 . Type Test ✓ Hardware & Software of the product verified against design standards . ✓ Product can be marketed after CE mark is obtained .
4 . Maintenance ( Preventive ) ✓ Planned Preventive Maintenance ( PPM ) referred as Pro-Active Maintenance .
✓ Scheduled inspections & tests to verify the safety & operation are within acceptable levels & criteria .
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3 . Acceptance ( T & C )
✓ Verify the device delivered in acceptable condition , without fault & available with accessories .
✓ Electrical Safety & Performance test as part of reference for future maintenance .
MS IEC 60601 applies only to newly install Medical Electrical Equipment , Medical Electrical systems , Information Technology Equipment used in medical electrical application , and all other devices forming part of Medical Systems , hereinafter referred to as Equipment and / or systems .
MS IEC 62353 Medical Electrical Equipment – recurrent test and test after repair of Medical Electrical equipment , defines the requirements for electrical safety testing of Medical Electrical equipment and systems during routine intervals .
Figure 11 : Area of MS IEC 60601 and MS IEC 62353 on EST
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