Hi, See below for answers to your questions. In summary, IEC 60601-1, Clause 56.11 does not allow this type if construction.
Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail [email protected] Dear All, One of the sections in the medical equipment standard (IEC 601-1) requires that handheld and foot-operated control devices and their cables be in circuits not more than 25 Vac or 60 Vdc or peak value separated from the mains by an acceptable method as specified in the standard. Question: Does this requirement apply to a a hand-held applied part with push-button switches supplying high voltages to the patient? Answer: Yes. This type of construction is not allowed. Question: Are the limits 25 Vac or (60 Vdc or 60 Vpeak)? Answer: Yes. The limits are the SELV limits for medical equipment. See Clause 2.4.3. Question: Are the limits 25 Vac OR 60 Vdc OR any peak value if separated from the mains by an acceptable method? Answer: No. Question: What is the rationale behind the requirement? Why can't someone have a 230 V rated foot-operated device which fully complies with the requirements or have a 1000 V applied part complying with the requirements? Answer: Don't know. My guess is that they did not want to take the chance of someone inadvertently using a SELV control on a mains circuit. Regards, PETER S. MERGUERIAN MANAGING DIRECTOR PRODUCT TESTING DIVISION I.T.L. (PRODUCT TESTING) LTD. HACHAROSHET 26, P.O.B. 211 OR YEHUDA 60251, ISRAEL TEL: 972-3-5339022 FAX: 972-3-5339019 E-MAIL: [email protected] Visit our Website: http://www.itl.co.il --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators). --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators).
