A small correction to Peter answer: The Standards Institution of Israel (SII) would the only body which issue a LETER recognized by Israeli Customs.
Tests for import products in Israel can be conducted by any of the Designated Laboratories. This designation is done by the Israeli Standardization Commissioner which belong to the Israeli Ministry of Industry, Trade and Labor. For Medical Electrical Equipment in Israel, IEC 60601-1 (with small deviation-see below) and IEC 60601-1-2 (without deviations) are the accepted standards. 4.7 A. Equipment that is to be connected to the mains, shall be intended for one of the following voltages and frequencies: Nominal frequency of 50Hz. Nominal voltage of 230V for portable and hand-held equipment. Nominal voltage 230V, for one phase equipment with input power not exceeding 4kVA. Nominal voltage 400V, for multiphase equipment. B. It is allowed to connect to the mains other equipment, with the following ratings: One phase equipment, for the range of 220 to 240 Volts. Multiphase equipment, for the range of 380 to 440 Volts. The equipment shall comply with all the requirements of the standard, while being connected to the above mentioned mains frequencies and voltages, as if it was marked for 50Hz and 230 or 400 Volts. 36 Change clause 36. - EMC – to: The equipment shall comply with the requirements of SI 1011 part 1.2 (IEC 60601-1-2). The steps which need to followed to enter in the Israeli Market are as follow: The product (Medical Electrical Equipment) which will enter (first time) in Israel shall be evaluated (full tested or assessed based on a CB Certificate+TR) according 601-1 – based on this evaluation (which can be done by Israeli Designated Laboratories: SII, ITL-Israel Testing Laboratories and Hermon Laboratories) SII shall issue the Letter for Customs and build a “prototype” file. Based on this file, for each future shipping, a sample named “shin” will be assessed by SII for conformance with the “prototype”. Our lab can assist all which are interested on Israeli market. I hope that the above clarify the issue. Steli Loznen, M.Sc., SM-IEEE Q.A & Certification Manager I.T.L (Product Testing) Ltd. Convener IEC/TC62/SC62A/WG17 1 Bat Sheva St., POB 87 Lod 71100, Israel V: +972-(0)8-9153100 Ext.203 F: +972-(0)8-9153101 M: +972-(0)54-7245794 st...@itl.co.il http://www.itl.co.il From: peter merguerian [mailto:pmerguerian2...@yahoo.com] Sent: Tuesday, December 08, 2009 6:37 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Medical devices and Israel Derek, Do you have the harmonized tariff code? The Standards Institution of Israel (SII) would the the only laboratory in Israel able to test your product for import. I can help you gain the SII approval if you wish if you serne me the product brochure together with any test reports you might have for safety and emc Thanks, Peter --- On Mon, 12/7/09, Derek Walton <lfresea...@aol.com> wrote: From: Derek Walton <lfresea...@aol.com> Subject: Medical devices and Israel To: "IEEE EMC & SAFETY PSTC" <emc-p...@ieee.org> Date: Monday, December 7, 2009, 2:34 PM Hi folks, A while back I tested a light box that goes on the wall of a Dr's office. It's used for showing X-Ray films. I was asked to perform testing to EN60601-2, which we did. I have been asked to produce an EMC Certificate, but I must have missed where the requirements for this came from. Can anyone enlighten me please. Additionally, this morning, I'm informed that to import into Israel, the test has to be performed by a Certified Electronics Laboratory: what is one of those? Many thanks, Derfel Walton L F Research - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org <http://us.mc1120.ma l.yahoo.com/mc/compose?to=emc-p...@ieee.org> > All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. 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