Hello Everyone, I read two or three messages about the FDA and any emission requirements...
I would like to know: What does the FDA require in terms of immunity? Surely any standards implied by a 510(k) registration would only be valid for the required conformance at the time when the registration was made? If the FDA does not require immunity standards, is there an equivalent database to that held by the CDRH with the 510(k)'s of medical equipment which lists these details for each registered device? In South Africa, IEC 60601-1-2 is not legislated in any form, according to the South African Bureau of Standards, and it is quite difficult to get EMC information about medical equipment, especially older instruments. Best regards, Kevin Williams -- ----------------------------------------------------------------------- Dr Kevin Williams, MIEEE Electromagnetic Software and Systems (EMSS) Stellenbosch, South Africa [http://emss.co.za] Tel/Fax: +27 21 880-1880/+27 21 880-1936 PGP Fingerprint [0F 55 2E 51 63 05 C4 AC 01 C7 53 67 2E 47 6C 2A] --> Please note our new FAX number. -----------------------------------------------------------------------
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