Industry (and international) standard as listed by AAMI (Association for the Advancement of Medical Instrumentation):
IEC 60601-2-31:1994 -- Medical electrical equipment, Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source Item: Final Document Type: International Standard Abstract: Specifies the particular safety requirements for external pacemakers. Format: Print Publication Date: 01-Oct-1994 Availability: Actual Order Notes: Available in the U.S. from ANSI. Category: Electromedical equipment Subcategory: Therapy and surgery; Cardiovascular Activity: STANDARDS Keywords: medical equipment, pacemakers, safety, power source, electromedical equipment Staff Contact: [email protected] Project Type: New document Project Status: Completed Project Notes: Harmonized; mandate BC/CLC/93-01 (MDD) Document Status: Current Ballot Committee: IEC/SC 62D, Electromedical Equipment Committee Author: IEC/SC 62D/WG 06, Cardiac pacemakers Tag: AAMI/PC, Pacemaker Committee FDA Recognition Info: FDA-recognized Extent Of Recognition: Complete standard for SAFETY ONLY Link to FDA List: Choose Category "Cardiovascular/Neurology" Bob Martin, P.E., N.C.E. Sr. Technical Manager Intertek Testing Services NA, Inc. ETL SEMKO 70 Codman Hill Road Boxborough, MA 01719 Tel (978) 263-2662 Fax (978)263-7086 www.etlsemko.com [email protected] <mailto:rfm@[email protected]> -----Original Message----- From: [email protected] [ <mailto:[email protected]> mailto:[email protected]] Sent: Friday, July 19, 2002 4:39 AM To: [email protected] Subject: Pacemakers Is anyone aware of any radiated immunity standards or test limits for pacemakers (national, international, or industry)? Bob Heller 3M Product Safety, 76-1-01 St. Paul, MN 55107-1208 Tel: 651- 778-6336 Fax: 651-778-6252 ------------------------------------------- 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/> 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] All emc-pstc postings are archived and searchable on the web at: <http://ieeepstc.mindcruiser.com/> http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- 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] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
