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Medical Device Testing - IEC 60601-1 & 60601-1-2 Standards

Project Description

MULTIPLE TESTING
MULTIPLE SAMPLES
CHINA ILAC-MRA, CNAS and ISO 17025-certified independent medical device testing laboratory needed for IEC 60601-1 and IEC 60601-1-2 testing (Medical electrical equipment: General requirements for basic safety and essential performance & Collateral Standard: Electromagnetic disturbances) per latest released versions, amendments and editions.
We need to have the devices certified for Electrical Safety and EMC compatibility.
Before sharing quotation kindly share the accreditation certificates with ILAC-MRA and CNAS and ISO 17025 certificate. Also approved scope of testing lab.

Attached information is strictly confidential and you should never disclose or share it. You can find the user manual of the device to be tested.
There are two families of devices combined in the user manual and we want to test only one family i.e., ?Standard D Laryngoscope? consisting of the following parts.
- 8 sizes of Macintosh Blades i.e, Mac 00,0,1,2,3,3.5,4,5
- 8 sizes of Miller Blades i.e, Miller 000,00,0,1,1.5,2,3,4
These blades have LED light source which will be powered by ready-to-use laryngoscope handles.
Note that there is no difference other than profile and sizes in blades which does not impact any electrical properties of the devices so you only need to perform the testing with one blade.

Regarding the handle its ready-to-use disposable handle will act as power source for laryngoscope blades. The handles are internally powered by 3 LR44 button cells and there is no external supply for the handle.

Project Information

Number:24-01344

Industry:Medical Devices

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