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LM386: LM386M-1/NOPB for Medical equipment

Part Number: LM386

Hi,

The customer is thinking to use LM386M-1/NOPB for medical equipment, Cataract surgery device. Cataract surgery device is "Class-III Medical equipment" by Global Harmonization Task Force (GHTF). Is there any concern to use LM386 for this kind of Class-III medical equipment? Or is there any special condition to use it under medical?

Regards,

Takashi Shinde