On Mon, 15 Sep 2003 14:05:10 +0200, ITL-EMC User Group <[email protected]> wrote:
> 1. we are looking for the subject information or a point of contact. Pharmaceutical and Medical Safety Bureau in the Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/) is the authority for medical devices. However, I'm not sure of the availability of required information. > 2. Is IEC 60601-1-2 sufficient or are there additional/other requirements. JIS T 0601-1-2 would be applicable as the EMC standard for most medical devices, and JIS T 0601-1-2 is harmonized with IEC 60601-1-2. So, in general, we can apply IEC 60601-1-2 as the product family EMC standard for medical devices to be sold in Japan. Some medical devices may have additional requirements specified in the product specific standards. Regards, Tom Tomonori Sato <[email protected]> URL: http://member.nifty.ne.jp/tsato/ This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
