Hi Gary, If your example is just a PC with medical software, then the answer to you question is found in the definition of Medical Electrical Equipment in 60601-1:
1.1 medical electrical equipment (hereinafter me equipment) Electrical equipment, provided with not more than one connection to a particular supply mains; and intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a patient; and that makes physical or electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or from the patient. Stand-alone equipment which has no direct influence on the patient is not MEE it's ITE, no matter what the software does. Brent DeWitt member IEC SC-62A MT-23 From: [email protected] [mailto:[email protected]]On Behalf Of Gary Stuyvenberg Sent: Thursday, March 11, 2004 4:22 PM To: [email protected] Subject: Medical Electrical Equipment I am looking for help in understanding what the following paragraph from IEC 60601-1-2 (Medical Electrical Equipment) means and the extent to which it applies...........for example, a PC with medical software installed on it. Thanks in advance. Gary Page 35 60601-1-2 ) IEC:2001(E) *36.202.1 GENERAL *d) Non-medical electrical equipment Non-medical electrical equipment that is supplied as part of a SYSTEM and the use of which in the SYSTEM can be reasonably expected not to affect the ESSENTIAL PERFORMANCE or safety of the SYSTEM if the non-medical electrical equipment exhibits DEGRADATION, is exempt from the IMMUNITY testing requirements of this standard, provided the non-medical electrical equipment complies with applicable international IMMUNITY standards. (For example see CISPR 24 for ITE and IEC 61326-1 for measurement, control and laboratory equipment.) The determination of reasonable expectation not to affect the ESSENTIAL PERFORMANCE or safety of the SYSTEM shall be based upon a risk analysis. This risk analysis is not required if the non-medical electrical equipment supplied as part of a SYSTEM is tested for IMMUNITY in accordance with 36.202. EOM _____ Do you Yahoo!? Yahoo! Search - Find what youre looking <http://search.yahoo.com/?fr=ad-mailsig-home> for faster.
