Gary, I think you also should consider comments in Annex AAA of IEC 60601-1-2:2001, Subclause 36.2020.1.d):
"Consideration should be given to ISO 14971 and IEC 60601-1-4 for this risk analysis. Non-medical electrical equipment often has IMMUNITY requirements that are different from those specified by this standard. The exclusion from IMMUNITY testing according to this standard of non-medical electrical equipment that is not expected to affect the ESSENTIAL PERFORMANCE or safety of the SYSTEM, if the non-medical electrical equipment exhibits DEGRADATION, permits the use in a SYSTEM of non-medical electrical equipment that may not comply with the requirements of this standard. An example of such equipment is a printer used in a SYSTEM in which the information to be printed remains in the memory of an EQUIPMENT until it is intentionally deleted, and the information can be re-transmitted to the printer and re-printed in the case of interference with printer operation. Instructions for use of the MEDICAL ELECTRICAL SYSTEM should caution the user to verify proper operation of the printer before deleting stored data. In contrast, a non-medical electrical equipment (e.g. ITE) used as a PATIENT monitoring central station would likely be subject to the IMMUNITY requirements of this standard, depending upon the results of a risk analysis, because loss or corruption of PATIENT information at the monitoring central station can reasonably be expected to affect the safety of the PATIENT. Once equipment that could affect the ESSENTIAL PERFORMANCE or safety of the SYSTEM has been identified, that equipment should meet the requirements of 36.202." Michael Gusel Principal Engineer Regulatory Affairs Department Tel. 201-995-8362 Fax. 201-995-8605 "Jon Griver" <[email protected]> Sent by: [email protected] 03/12/2004 05:51 AM Please respond to "Jon Griver" <[email protected]> To <[email protected]> cc Subject Fw: Medical Electrical Equipment Gary, A couple of points here, not necessarily directly related to your question on EMC. 1. If the 'medical' software can have a direct or indirect effect on the treatment the patient receives, then the software may be subject to the requirements of the FDA in the USA and the Medical Devices Directive in the EU. 2. If the PC is physically connected to a medical device (according to the definition below), then the PC is subject to the requirements of IEC 60601-1-1, the safety standard for electrical medical systems. The consequences of this are dependent on whether the PC is used close to the patient's bed. Even if it is not connected to a medical device, but is located close to the patient, IEC 60601-1-1 should be taken into consideration, as the patient could close a current loop by touching the PC. 3. The paragraph you quote from the EMC standard can be paraphrased as saying that if you do not test the PC to the immunity requirements of IEC 60601-1-2, then you must perform a risk analysis to examine whether immunity problems could detract from the patient's treatment. Regards, Jon Griver <http://www.601help.com/> http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 ----- Original Message ----- From: <mailto:[email protected]> Brent DeWitt To: <mailto:[email protected]> Gary Stuyvenberg ; <mailto:[email protected]> [email protected] Sent: Friday, March 12, 2004 4:32 AM Subject: RE: Medical Electrical Equipment 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
