Biomedical Design and Regulation

COPYRIGHT
Test Date：
Test Date：
Detachable cord measured separately, the maximum resistance for the protective earthing conductor is <0.2Ω
The resistance between any protectively earthed accessible metal parts and the protectiveearth terminal of equipment <0.1Ω .(Equipment with detachable mains cord removed)
Power supply cord is of an approved type
Cord grips effective
Plug pakes or transformer packs are of an approved type
5.2.5 PERMANENTLY INSTALLED EQUIPMENT
5.3.3PROTECTIVE EARTHING TEST
Class I equipment, fixed power supply cord, resistance form mains plug to accessible earthed parts<0.2Ω.
Class I equipment,detachable power supply cord, resistance from main plug to earthed accessible metal parts<0.3Ω.
Test Date：
Test Date：
5.2.1GENERAL INSPECTION
Pass/Fail
Pass/Fail
Equipment undamaged
Internal assemblies secure
Accessories, connectors, plugs and sockets undamaged
Note:Should not be less than 80% of the acceptancetest value if under 10MΩ
5.3.5EARTH LEAKGE CURRENT TEST
Class lequipment, 500μAmax,no fault condition
Class l equipment, 1.0mA max.,neutral open
ANYTOWNHOSPITAL
BIOMEDICAL ENGINEERING DEPARTMENT
HOSPITAL: _________________ WARD/DEPT: ______________ BmE No: ______________
EQUIPMENGT . No: ____________________________________ MODEL : ______________
Note:For permanently installed equipment,refer to AS/NZS 3003.
5.3.4 INSULATION RESISTANCE TESTS
Mains parts to protective earth
Mains to equipment enclosure
CF equipment ,50μA max.,earth or neutral open
&
BF&B equipment,100μA max.,normal condition
BF&B equipment,500μA max., earth or neutral open
5.3.7 MAINS CONTACT CURRENT (CFμBF APPLIED PARTS ONLY)
Correctness and security of the equipment mounting
Cables secured and cannot become caught in mechanism
5.2.6SUSPENDED MASSES
Stops, brakes, interlocks safety devices on carriages, moveable
Mobile X-ray equipment,2.5mA max.,no fault condition
Mobile X-ray equipment,5mAmax.,neutral open
5.3.6 APPLIED PART LEAKAGE CURRENT
CF equipment,10μA max., normal condition
Wheels, castors and brakes are in working order
5.2.2 MARKINGS REQUIRED AT ACCEPTANCE REMAIN LEGIBLE
5.2.3 MAINS SUPPLY CONDUCTORS
Permanently installed equipment, power supply cords plugs, appliance co.per patient connection
BF equipment，5.0mA max.-all applied parts bridged together
Remarks……………………………………
Tests completed by………………………..
equipment
Electrical cable not subjected to undue strain or friction
Supporting cables examined for wear and adequate anchorage
Mechanical mountings supporting suspended masses in order
Rewirable mains plugs and sockets clear backed
Accessories, connectors, plugs and sockets undamaged
Security and alignment of control knobs
Fuse ratings correct