G/TBT/N/ISR/915  
 
19 April 2016  
(16-2190)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: ISRAEL  
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: Israel WTO-TBT Enquiry Point 
Name and address (including telephon e 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 Economy and Industry 
Tel: + (972) 3 7347501 E-mail: Yael.Friedgut@economy.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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Medical electrical 
equipment (HS: 9018, 901910, 9405, 940591; ICS: 11.040) 
5. Title, number of pages and langua ge(s) of the notified document: SI 60601 part 1 – 
Medical electrical equipment:  General requirements for basic safety and essential performance (415 pages, in English; 10 pages, in Hebrew) 
6. Description of content: Revision of the Mandatory Standard SI 60601 part 1, dealing with 
medical electrical equipment. This draft standard revision adopts the International Standard 
IEC 60601-1 – Edition 3.1: 2012-08 with a few changes in the normative references that 
appear in the standard's Hebrew section.  Th e major differences between the old version and 
this new revised draft standard are an outcome of the adoption of a newer version of the International Standard.  
The replacement of SI 1011 part 1 with SI 60601 part 1 was first published on 
28 May 2008 (announced in G/TBT/N/ISR/192) but the entry into force was postponed until 31 December 2017. Therefore this new revision will apply together with the old 
standard's versions: SI 1011 part 1 (March 1998) and SI 60601 part 1 (March 2008), from 
publication in Israel Official Gazette until 31 December, 2017. During this time medical electrical equipment may be tested according to any of these standards. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety  
8. Relevant documents:  
 Israel Mandatory Standard SI 1011 part 1 (March 1998) 
 Israel Mandatory Standard SI 60601 part 1 (March 2008) 
 International Standard IEC 60601-1 – Edition 3.1: 2012-08 G/TBT/N/ISR/915 
 
- 2 - 
 
  9. Proposed date of adoption: To be determined 
Proposed date of entry into force: This new revision will appl y together with the old 
standard's versions: SI 1011 part 1 (March 199 8) and SI 60601 part 1 (March 2008), from 
publication in Israel Official Gazette until 31 December, 2017. During this time medical 
electrical equipment may be tested according to any of these standards 
10. Final date for comments: 60 days from notification 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body: 
http://www.economy.gov.il/st andartization/WTO_TBT/ISR_ Text/SI60601Par t1_May15.pdf