. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/ISR/581 
2 March 2012  
 (12-1206) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  ISRAEL  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Israel WTO-TBT Enquiry Point  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
Israel WTO-TBT Enquiry Point  
Ministry of Industry, Trade and Labor Tel:  +(972) 3 7347502 Fax:  +(972) 3 7347626 E-mail:  Yael.Friedgut@moital.gov.il  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medical electrical 
equipment (ICS: 11.040.60; HS: 8413.70, 8413.81, 9018, 9019.10, 9019.20, 9402, 9405.10, 
9405.20 and 9405.40). 
5. Title, number of pages and language(s) of the notified document:  Medical electrical 
equipment: Particular requirements for the ba sic safety and essential performance of 
ultrasonic physiotherapy equipment (7 pages in Hebrew and 66 pages in English and French).   
6. Description of content:  Revision of the Mandatory Standard  SI 1011 part 2.5 to be replaced 
with 60601 part 2.5. This draft standard re vision adopts the Intern ational Standard IEC 
60601-2-5 - Edition 3.0: 2009-07. Most of the changes included in this revision are due to the changes introduced into the last revision of the adopted International Standard. These changes 
include the following:  
- Adaptation to the Mandatory Standard SI  60601 part 1 and partic ular requirements 
 for essential performan ce (paragraph 201.4.3.101),  
- Adds new maintenance instru ctions (paragraph 201.7.9.2.1), 
- Adds new requirement for dielec tric strength (paragraph 201.8.8.3), 
- Amends the requirements with respect to excessive temperature of the transducer's 
 surface (paragraph 201.11), 
- Amends the ultrasonic characteristics according to the International Standard IEC  61689: 2007, 
- Amends the definition of effective radiating area (paragraph 201.3.207). G/TBT/N/ISR/581 
Page 2  
 
  Both the old standard and the new revised standard  will apply from their date of publication in 
the Israel Official Ga zette until December 31, 2012. During this time devices may be tested 
either according to the old or the new revised standard. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human safety a nd lowering of trade barriers.  
8. Relevant documents:    
- Mandatory Standard SI 1011 part 2.5 (June 2002). 
- International Standard IEC 60601-2-5 - Edition 3.0: 2009-07. 
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 
Generally 60 days after publication in Israel's 
Official Gazette, Se ction of Government 
Notices 
10. Final date for comments:  60 days from date of notification 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:  
http://www2.moital.gov.il/cmstama t/rsrc/tkina/SI60601Part2-5.pdf