RE: IEC 60601-1-2 Second Edition

2002-02-05 Thread Jim Conrad
if you want more information regarding this. You asked: Has anyone had any success in doing a risk analysis to use lower immunity compliance levels than specified in IEC 60601-1-2, Second Edition, Section 36.202.1 a) or using different compliance criteria (36.202.1 j))? The risk analysis

RE: IEC 60601-1-2 Second Edition

2002-02-05 Thread Kevin Hight
-Original Message- From: Ned Devine [SMTP:ndev...@entela.com] Sent: Tuesday, February 05, 2002 8:24 AM To: IEEE EMC/Product Safety (E-mail) Subject:IEC 60601-1-2 Second Edition Hi, I need some help from the EMC

IEC 60601-1-2 Second Edition

2002-02-05 Thread Ned Devine
Hi, I need some help from the EMC experts. According to FDA Acting Chief of the Brach I am dealing with, since the FDA has recognized IEC 60601-1-2 Second Edition (October 2001), then ...If they submit a new 510(k) (or even a modification for an existing device) and we have recognized