Marque, It would appear that your epilation device is not a medical device according to the scope of the Medical Devices Directive (unless having unwanted hair can be considered a handicap!!). I would go for EN 60335-1 and check out the scopes of EN 60335-2-23 and EN 60335-2-8 to see if they are applicable.
Nevetheless, I believe that due diligence requires you to get a written opinion from an EU MDD Notified Body, or even a Competent Authority (e.g. the Medical Devices Agency in the UK), rather than depending on free advice (like this). Regards Jon Griver http://www.601help.com The Medical Developers' Guide to IEC 60601-1 > Subject: standard for Epilation device? > > > > Greetings, > > We are in the process of developing an epilation device -(unit used in > beauty salons to permanently remove unwanted hair - known as > "electrolysis") > Does anyone have any idea what EU standard would be most suitable to > apply to a device such as this. Is it medical since a needle is inserted > into the dermus layer of the skin, or would it come under more of a > household standard such as EN60335? Beauty salons are normally found in > shopping centres so could this imply some sort of light industrial > standard such as EN61010? > > Any help would be greatly appreciated, > > kindest regards, > > Marque Crozman > Research & Development Hardware Engineer > EMC Test & Complience Engineer > ---------------------------------------------------------------------- > Innotech Pty Ltd > P.O. Box 292 Sunnybank QLD 4109 Australia > Phone. +61 7 3841 1388 Fax. +61 7 3841 1644 > E-Mail - [email protected] > Web - http://www.innotech.com.au > ---------------------------------------------------------------------- > > > > ------------------------------------------- > 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.
