Hi Ned, I think everyone is asking the same question. You have received the correct interpretation from the FDA. The 2nd edition is effective as of 10-2001 and if you claim compliance with it on your 510k, the FDA will not come back and ask for more information regarding EMC. They are however reasonable and do not expect manufactures to comply on such short notice but they then also reserve the right to come back and ask you additional questions regarding the EMC performance of you product which may include why you did not choose to comply with the 2nd edition of 60601-1-2. Call me if you want more information regarding this.
You asked: "Has anyone had any success in doing a risk analysis to use lower immunity compliance levels than specified in IEC 60601-1-2, Second Edition, Section 36.202.1 a) or using different compliance criteria (36.202.1 j))? " The risk analysis that is call for in the 2nd edition is only to determine which "functions" of the equipment will be tested for immunity. Only those functions that are associated with "essential performance" need be tested. A risk analysis does not allow "essential performance" to pass at reduced levels. Yes, "Clause 6.8.3.201 a) 5), "These justification shall be based only on physical, technological or physiological limitations..." pretty much preclude the use of lower limits?" Your justification for lower immunity levels must be based on physical, technological or physiological limitations. You stated and asked: "The device in question meets IEC 60601-1-2 First Edition, but will not pass the requirements in the Second Edition. Can the "justification" be that since there are no known risks on the device, the current level of immunity is adequate?" No you cannot use this as a justification because it is not based on physical, technological or physiological limitations of your equipment. Please contact me directly if you need more help. Best regards, Jim -----Original Message----- From: [email protected] [mailto:[email protected]]On Behalf Of Ned Devine Sent: Tuesday, February 05, 2002 4:24 PM To: IEEE EMC/Product Safety (E-mail) Subject: IEC 60601-1-2 Second Edition Hi, I need some help from the EMC experts. According to FDA Acting Chief of the Brach I am dealing with, since the FDA has recognized IEC 60601-1-2 Second Edition (October 2001), then "...If they submit a new 510(k) (or even a modification for an existing device) and we have recognized the more recent standard, then they would need to comply with the new standard." Making the new edition immediately effective seems a little harsh. I am appealing his interpretation, but I don't know if I will have any luck. Has anyone had any success in doing a risk analysis to use lower immunity compliance levels than specified in IEC 60601-1-2, Second Edition, Section 36.202.1 a) or using different compliance criteria (36.202.1 j))? Or does Clause 6.8.3.201 a) 5), "These justification shall be based only on physical, technological or physiological limitations..." pretty much preclude the use of lower limits? The device in question meets IEC 60601-1-2 First Edition, but will not pass the requirements in the Second Edition. Can the "justification" be that since there are no known risks on the device, the current level of immunity is adequate? Thanks Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax [email protected] e-mail ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
