G/TBT/N/UGA/1148  
17 December 2019  
(19-8775) 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:  UGANDA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Uganda National Bureau of Standards  
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:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 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):  Non-
absorbable surgical sutures; - Sterile surgical catgut, similar sterile suture materials and 
sterile tissue adh esives for surgical wound closure; sterile laminaria and sterile laminaria 
tents; sterile absorbable surgical or dental haemostatics (HS 300610); Surgical 
instruments and materials (ICS 11.040.30)  
5. Title, number of pages and language(s) of the notified document:  DUS DEAS 
1019-2:2019, Surgical sutures — Specification — Part 2: Non -absorbable, First edition 
(29 page(s), in English)  
6. Description of content:  This Draft Uganda Standard specifies the requirements, 
sampling and test methods for non -absorbabl e surgical sutures  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Quality requirements; 
Harmonization; Reducing trade barriers and facilitating trade  
8. Relevant documents:   
1. ISO 5832 -1, Impl ants for surgery — Metallic materials — Part 1: Wrought 
stainless steel  
2. ISO 10993 (all parts), Biological evaluation of medical devices  
3. ISO 24153, Random sampling and randomisation procedures  
4. DEAS 1018, Surgical needles — Specification  
5. British Pharmacopoeia, 2017, published by The Stationery Office on behalf of 
the Medicines and  
6. Healthcare Products Regulatory Agency  
7. ISO 11135 (both parts), Sterilization of health care products — Ethylene oxide  
8. ISO 11137 (all parts), Sterilization of health care products — Radiation  G/TBT/N/UGA/1148  
 
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  9. ISO 17665 (all parts), Sterilization of health care products — Moist heat  
10. US Pharmacopoeia 40  
11. US 1958 -2:2019, Surgical sutures — Specification — Part 2: Non — absorbable  
12. British Pharmacopoeia, 2017, published by The Stationery Office o n behalf of 
the Medicines and Healthcare Products Regulatory Agency  
13. ISO 11135 (both parts), Sterilization of health care products — Ethylene oxide  
14. ISO 11137 (all parts), Sterilization of health care products — Radiation  
15. ISO 17665 (all parts), Sterilization  of health care products — Moist heat  
16. US Pharmacopoeia 40  
17. US 1958 -2:2019, Surgical sutures — Specification — Part 2: Non — absorbable  
9. Proposed date of adoption:  June 2020  
Proposed date of entry into force:  Upon declaration as mandatory by the Minister for 
Trade, Industry and Cooperatives.  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2019/TBT/UGA/19_7274_00_e.pdf