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Medical Electrical Equipment Testing Guide

source:This site   release time: 2018-05-24 11:28:55   Browsing:388次  Font size: [大] [中] [小]
5 Notes of diagnostic X-ray devices before testing:6 Notes of infrared light therapy devices before testing:Lists of critical component partsObjectManufacturer trademarkType m

1.  Notes of Electrical Medical equipment testing:
1) For improving the testing efficiency it is recommended self-testing before sending the equipment to test center.
2) Please confirm the certificates of the critical components is complete and the model、manufacturer/factory  on the certificates are complied with the critical components used.
Critical components used in mains part:Plug; Connector; Cord set; Mains switch; Appliance inlet;Fuse;Fuse-holder; Internal electrical wiring ; Mains transformer; Switching mode Power Supply; X capacitor and Y capacitor of Mains parts, etc.
3) For a imported equipment it should pay attention that the name of the product should be complied with product catalog requirements of SFDA and the safety appendix should be complied with the IEC report. In addition, it also should pay attention that if you could provide IEC 60601-1 test report and the qualification of the third party testing institute. If there is no IEC60601-1 report, it would be request to carry out all tests under current inspection rules.
4) There are no marks in Chinese on most imported products and it will take long time to make Chinese marks and to be authorized by the foreign manufacturer. Please do primary check according to Order 10 of SFDA before testing to ensure the testing going smoothly.
5) Before testing we recommend that you check the structure conforms to requirements of safety standards and the effectiveness of isolation.
6) We also recommend that you confirm the test methods of your product standard is detailed enough and could be implemented.
eg:Before auditory evoked potentials amplifier testing,it should be confirmed the input signal amplitude, frequency, And the input electrode location on the circuit board(imported product).
7) Please carefully check the product manual contains all contents the standard required according to product standard take GB9706.1 and the corresponding particular requirments standard as reference。
8) It is recommended to provide electrical insulation diagram of your product so that subsequent testing could be carried out smoothly.
2. Notes of injection pump/ infusion pump before testing.
It is critical that the manual contents meet the GB9706.27 national standard requirements for injection pump/ infusion pump.
3. Notes of forendoscope and surgical Luminaire before testing.
1) It is recommend that client is familiar with your product , product standard , national standard and particular standard in order to communicate smoothly with testing engineer.
2) Please confirm technical information of your product before testing:
a) Model and/or type reference,manufacturer/factory and all parts of product.
b) Mark in Chinese of imported product shall be made and shall be consistent with the original mark (foreign).
c) Please take IEC report as reference when compile safety requirements part of product standard. Please promptly communicate with manufacturer/factory in case of need so as to test smoothly. Performance specifiction should be clear and the description should be in conformity with corresponding requirements.
d) Please list principal samples because Endoscopically-used accessories are more than other devices. Please do not change accessories in the list during the testing so as to test smoothly.
4. Notes of ECG and patient monitors before testing: 
1) Accessories of the device should be provided completely (especially lead wirings and electrodes), which should comply with the specification and model as product standard claimed. If there are inconsistencies, please provide the accessories which are product standard required, or modify the product standard to achieve consistency.
2) Please provide certificates of the critical components: optocoupler of applied part, transformer of applied part(if it has certificate).Please provide information of critical components as more as possible.
3) Please do self-testing follow the particular standard, like “Defibrillation electrode polarization recovery time”, “The instructions of the abnormal working” , and so on, to confirm that the results can meet the requirements. Please pay more attention to “Defibrillation electrode polarization recovery time” if you provide ECG with reusable electrodes (eg, limb folder).
4) Please confirm that air clearance and creepage distance of the isolation of mains part and applied part meet the standards.  It involves the modification of the product structure if failed meet the requirements to, So please check before testing.

5.         Notes of diagnostic X-ray devices before testing:

Project

Content

Remarks

Marking on the outside

Major components of the equipment should identified with, eg: Equipment label ,Hypertension label, Tube assembly label, Limited beam device label, Patient support device label, Electrical power supply cabinet label, Image system related label, Grids label, Computer system label, etc. Label should be clear, durable, comprehensive.

Certificate of the critical components

eg: PVC insulated flexible cables and wires, Single-phase Two-pole Non-rewirable Plug, Cord set, PVC sheathed flexible cables and wires, Connector,  Emergency stop switch,  Breaker, Fuse, Fuse-holder,  Air break switch,  (Internal powered equipment) Rechargeable battery, Switching mode power supply,  Relay, Computer(GB4943),  Monitor(GB8898),etc. Please submit the certificates of critical components associated with the mains of the device. Please fill the“Lists of critical component parts ”as follows. Submit it with the certificates.

Transformer

three,include: One non-impregnated transformer used for inspection of structure, Two impregnated transformer used for testing of short-circuit and overload. Please send a number of the primary and secondary transformer protection devices (such as fuses, thermal circuit breakers, etc.) ; Fill the notice of transformer sample delivery.

6.         Notes of infrared light therapy devices before testing:  

Project

Content

Remarks

Marking on the outside

Major components of the equipment should identified with,eg: Equipment label , “Be ware of overheating”, “Be ware of dumping scalding” in the treatment head, etc. Power and wavelength of infrared light, Power and wavelength of polarized light, etc. Label should be clear, durable, comprehensive.

Certificate of the critical components

eg: PVC insulated flexible cables and wires, Single-phase Two-pole Non-rewirable Plug, Single-phase Two-pole Non-rewirable connector, Cord set, Appliance inlet , Emergency stop switch, Key switch, Rocker switch , Fuse, Fuse-holder, Switch power supply, etc. Please submit the certificates of critical components associated with the mains of the device, Please fill the“Lists of critical component parts ”as follows. Submit it with the certificates.

Transformer

three,include: One non-impregnated transformer used for inspection of structure, Two impregnated transformer used for testing of short-circuit and overload. Please send a number of the primary and secondary transformer protection devices (such as fuses, thermal circuit breakers, etc.) ; Fill the notice of transformer sample delivery.

Switching power supply

Two switch power supply used for testing of short-circuit and overload. Please wiring the actual output of the switch power supply, and make clearly signs if there are two groups of the output.
Lists of critical component parts
Object Manufacturer/trademark Type/model Technical data Certified by
PVC insulated wiring XXXX Corp. 227IEC53 (RVV) 300/500 2×1.0 CCC No.:XXXXXXXXXX
Fuse XXXX Ltd T8AH250V 8A 250V CQC No.:CQCXXXXXXX
Cartridge fuse XXXXXX Ltd F10AL250V 5mm×20mm F10AL250V UL No.:XXXXXXXXXX
AC contactor XXXXXX Corp. GSC 220V TUV No.:XXXXXXXXXX
Note: The content filled above is a demonstration, the form should be filled as actual critical components.

(from Beijing Institute Of Medical Device Testing)

 

 

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