Type of Notification
regular notification
Date of Distribution
2018.08.07
WTO Country
Agency Responsible
Israel WTO-TBT Enquiry Point
Regions Affected
Israel WTO-TBT Enquiry Point Ministry of Economy and Industry Tel: + (972) 3 7347501 E-mail: Yael.Friedgut@economy.gov.il
Notified Document Details
<p style="margin:2px !important;">SI 1268 part 5 - Syringes and needles: Sterile single-use syringes, with or without needle, for insulin</p>
Product
ICS Code
Covered Products
<p style="margin:2px !important;">Medical syringes</p>
Description of Content

Revision of the Mandatory Standard SI 1268 part 5, dealing with medical syringes. This draft standard revision adopts the International Standard ISO 8537 - Third edition: 2016-03-15, with a few changes that appear in the standard's Hebrew section.  The major differences between the old version and this new revised draft standard are as follow:

    • Changes the standard's normative references (paragraphs 2 and 5.9.2);
    • Adds new colour codes for higher concentration of insulin (paragraph 5);
    • Changes the information requirements supplied by the manufacturer both for the user packaging and for the storage container (paragraphs 7.5 and 7.6);
    • Changes the test method for determination of force required operate piston from manual to an automatic test (Annex C).

 

Relevant Documents
  • Israel Mandatory Standard SI 1268 part 5 (August 2002) and Amendment 1 (January 2007);
  • International Standard ISO 8537 - Third edition: 2016-03-15.
Final Date of Comments
2018.10.06
Document Online Link (EN)
Notified Under
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