Hi to all involved in this discussion, This is the relevant definition from the IVD (In-vitro Diagnostics Directive - 98/79/EEC). Sorry about the length of the quote.
"in vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: - concerning a physiological or pathological state, or - concerning a congenital abnormality, or - to determine the safety and compatibility with potential recipients, or - to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. 'Specimen receptacles` are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; " Having read this, it seems to me that if the version of the centrifuge has any characteristics that make it "intended by their manufacturer to be used for in vitro diagnostic examination", then it falls under the IVD. If not, and the same model is also sold for non-medical use, then its LVD. Regards, Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 From: "Smith, Paul J." <[email protected]> To: "T.Sato" <[email protected]> Cc: <> Sent: Wednesday, October 15, 2003 4:45 PM Subject: RE: centrifuges and the MDD > > > Tom, > > Our centrifuges are not used to process anything that is reintroduced back into a patient. Accordingly couldn't these centrifuges be considered only as general laboratory equipment covered by the LVD standards IEC 1010 / EN 601010 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use and 1010-2-020, Part 0-020 Particular Requirements for Laboratory Centrifuges ? > > Regards, Paul S > -----Original Message----- > From: T.Sato [mailto:[email protected]] > Sent: Wednesday, October 15, 2003 9:30 AM > To: [email protected] > Subject: RE: centrifuges and the MDD > > > > On Wed, 15 Oct 2003 08:06:26 -0400, > "Ned Devine" <[email protected]> wrote: > > > If the centrifuge is used for blood, then it is covered under the MDD. > > Maybe the In-Vitro Directive, if the centrifuge is intended to > be used for in-vitro diagnostic applications. > > Regards, > Tom > > -------------------------------------------------- > Tomonori Sato <[email protected]> > URL: http://member.nifty.ne.jp/tsato/ > 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
