Ron and Ned,
I should add that none of our centrifuge products have direct patient contact. They are generic lab centrifuge equipment. Paul S From: Ronald R. Wellman [mailto:[email protected]] Sent: Wednesday, October 15, 2003 10:30 AM To: Ned Devine; Smith, Paul J.; [email protected] Subject: RE: centrifuges and the MDD Hello Ned, Here is a copy of Rule 3: --- 1.3. Rule 3 All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class llb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa. --- If a centrifuge is "intended" to modify blood for infusion into the human body, you are probably right about it needing to be Class IIa. However, centrifuges are used for many other things other than spinning body liquids. It would appear that the centrifuge manufacturer will need to make the appropriate claims for their product if they want it to be considered a medical device under the MDD. Best regards, Ron Wellman At 08:06 AM 10/15/2003 -0400, Ned Devine wrote: >Paul, > >If the centrifuge is used for blood, then it is covered under the MDD. >It is classified under Rule 3 and is a Class IIa device. See the MEDDEV >Guidelines for the Classification of Medical Device. "Centrifugation of >blood to prepare it for transfusion or autotransfusion." > > >Ned Devine >Entela, Inc. >3033 Madison Ave. SE >Grand Rapids, MI 49548 > >Phone: 616 248 9671 >Fax: 616 574 9752 >e-mail: [email protected] >www.entela.com > > > >-----Original Message----- >From: Smith, Paul J. [mailto:[email protected]] >Sent: Tuesday, October 14, 2003 5:11 PM >To: [email protected] >Subject: centrifuges and the MDD > > > >List Members, > >There is persistent question on whether centrifuges are covered under >the MDD or LVD. Can anyone point to any info that specifically calls out >centrifuges as product covered under the MDD? > >I have found only a very vague description of covered products but >nothing that conclusively includes centrifuges as a product covered >under the Medical Device Directive. > >Best Regards, > >Paul J. Smith >Standards Engineer > > >------------------------------------------- >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 > >This message is confidential and intended only for the individual to whom >or entity to which it is addressed. If you are not the intended recipient >or addressee, or an employee or agent responsible for delivering this >message to the addressee, you are hereby notified that any dissemination, >distribution, or copying, in whole or part, of this message is strictly >prohibited. If you believe that you have been sent this message in error, >please do not read it. Please immediately reply to sender that you have >received this message in error. Then permanently delete all copies of the >message. Thank you. > > > > >------------------------------------------- >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 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
