Dear Bill and others, Clause 4.1 of IEC 60601-1 states that the tests in the standard are type tests, i.e. they are intended to test the design of a product.
Clause 4.1 of Appendix A (rationale) discusses production tests and suggests leakage current, dielectric strength and earth continuity, where applicable. Production testing is closely linked with the subject of product liability. If you have a license >from a test house to put their label on your product, the test house is also in the product liability firing range, and therefore usually demands production testing as part of the terms of the license for the use of their label. The actual tests required depend on the nature of the product, and may, to some extent, be the subject of negotiation on the basis of engineering judgement. If you do not use a test house label, and self declare, e.g. for CE marking, then its up to you to what extent you do production testing. Nevertheless, it is your responsibility to show that your production, and not just your design, is compliant; so both for this reason, as well as product liability reasons, you would be strongly advised to perform thorough production safety testing, as well as to make sure the results are recorded and traceable. Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 Hi, I am relatively new in this field, but here are some questions and my thoughts. How do agencies require 100% testing for electrical medical products? Are the requirements published somewhere, or are the tests specified by each agency, per product? I know one standard, UL 2601-1, that specifies production line tests, but it also states that the tests are "not an integral part" of the standard. At a particular 3rd party lab, the report that is issued after completion of 'type' testing includes the requirements for production line tests. This usually is based off Clauses 700-702 of UL 2601-1. The tests specified in these clauses include dielectric and ground continuity tests, but does not include leakage current testing. At another lab, the report doesn't specify any production tests and they expect you to determine the relevant production tests on your own. In this case, I do not know what happens if you decide not to do any production tests as my company typically does conduct production safety testing. Thanks, Delphina From: [email protected] [mailto:[email protected]] Sent: Monday, February 10, 2003 1:53 PM To: 'FastWave' Cc: [email protected] Subject: RE: Electrical Medical Product Production Testing I would find it hard to think of ANY agencies that WOULD NOT require 100% testing. I was at a product liability seminar at British Standards Institute many years ago and someone asked about sampling levels for Earth Bond and Earth Leakage on consumer goods. The BSI panel took some time to understand that the questioner was serious. A lot of us took mental (and written) note of the company name - to ensure that we would not purchase anything from them. Best regards Gregg From: [email protected] [mailto:[email protected]]On Behalf Of FastWave Sent: Monday, February 10, 2003 2:18 PM To: '[email protected]' Subject: Electrical Medical Product Production Testing Does anybody know any Certification Agencies and/or Standards anywhere in the world requiring Production Line Leakage Current Testing on Electrical Medical Products? If so, does anybody have it in writing? Thanks for the help, Bill Bisenius ED&D, Inc. [email protected] <mailto:[email protected]> www.productsafet.com <http://www.productsafet.com> 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: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
