Brian, The text of IEC/EN 60601-1 does not relate to production testing, but the "General Guidance and Rationale" section at the end of the standard covers this issue under the guidance for Clause 4.1.
The section opens as follows: "In order to ensure that every individually produced item of equipment conforms to this Standard, the manufacturer and/or installer should carry out such measures during manufacture and/or installation assembly as to ensure that each item satisfies all requirements even if it is not completely tested individually during manufacture or installation". The text continues, describing considerations to be taking into account when deciding on suitable production tests, and closes as follows: "Suggested test parameters could be leakage current and dielectric strength. Where applicable, the continuity of protective earthing may be a major test parameter" So basically it says the manufacturer should use engineering judgement to chose the appropriate tests to ensure that production complies with the standard. In practice what happens is that if you have a test house label on your product, then that test house will specify the production tests it deems appropriate. If you are going on self declaration, then you have to decide on the tests yourself. However, even in this situation, you are probably subject to Notified Body audits under the EU Medical Devices Directive, and the auditor should let you know if he thinks your production tests are not suitable. There are obviously also legal liability issues involved. You should have a written engineering justification for the tests chosen, as well as written traceable records of production testing performed. Regards, Jon Griver www.601help.com The Medical Device Developer's Guide to IEC 60601-1 > > The good people of the PSTC group were very helpful last time; so I will go > to the well again... > > Other than the General section of my UL FUS procedures, I can find no > reference for required (100%) factory tests and test parameters. Is there an > IEC/EN60601-1 based factory test listing anywhere (normative or informative) > ? > > thanks much, > Brian O'Connell > Taiyo Yuden (USA), Inc. > > > ------------------------------------------- > 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.
