From: Doug Sutherland (wearable_at_earthlink.net)
Date: 2001-12-19 10:25:33
ePanorana Electronics Safety Pages
http://www.epanorama.net/links/safety.html
What are These Electrical Safety Standards Anyway?
http://www.biotek.com/biomed_application.asp?appid=71
Overview of IEC60601-1 Medical Electrical Equipment
http://209.35.218.36/downloads/IEC60601-1_Overview.pdf
The medical developer's guide to IEC 60601-1
http://www.601help.com/Other_601_Standards/other_601_standards.html
UL Europe can evaluate nearly every type of appliance or
electrical device power supply.
http://europe.dynamicweb.dk/Default.asp?ID=121
FDA Public Health Advisory: Unsafe Electrode Lead Wires
and Patient Cables Used with Medical Devices
http://www.fda.gov/cdrh/leadwire.pdf
FDA requiring IEC 601 & 801 for medical devices
http://www.fr.com/practice/pdf/fdaiec.pdf
Guide to inspections of electromagnetic compatibility
aspects of medical device quality systems
http://www.fda.gov/ora/inspect_ref/igs/elec_med_dev/emc14.html
FDA issues new guidance on medical device software and
electromagnetic interference (EMI) to/from medical devices
http://www.fr.com/practice/pdf/fdaemi.pdf
Draft Revision of FDA's Medical Device Software Policy
Raises Warning Flags
http://www.devicelink.com/mddi/archive/97/10/019.html
Guidance for Industry: FDA Reviewers and Compliance on
Off-The-Shelf Software Use in Medical Devices
http://www.validationstation.com/fdaregulations/ots_software/ots_software.txt
This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:35 BST