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 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
