G/TBT/N/UGA/1147  
17 December 2019  
(19-8774) 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):  
Absorbable surgical sutures; - Sterile surgical catgut, similar sterile suture materials and 
sterile tissue adhesiv es 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 docu ment:  DUS DEAS 
1019-1:2019,Surgical sutures — Specification — Part 1: Absorbable, First edition (23 
page(s), in English)  
6. Description of content:  This Draft Uganda Standard specifies the requirements, 
sampling and test methods for absorbable surgical su tures.  
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. British Pharmaco poeia, 2017  
2. ISO 11135:2014, Sterilization of health care products — Ethylene oxide  
3. ISO 11137 -1:2006, Sterilization of health care products -- Radiation -- Part 1: 
Requirements for  
4. development, validation and routine control of a sterilization process for medical 
devices  
5. ISO 11137 -2:2013, Sterilization of health care products -- Radiation -- Part 2: 
Establishing the  
6. sterilization dose  
7. ISO 11137 -3:2017, Sterilization of health care products -- Radiation -- Part 3: 
Guidance on dosimetric  G/TBT/N/UGA/1147  
 
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  8. aspects o f development, validation and routine control  
9. ISO 17665 -1:2006, Sterilization of health care products -- Moist heat -- Part 1: 
Requirements for the  
10. development, validation and routine control of a sterilization process for medical 
devices  
11. ISO/TS 17665 -2:2009, Sterilization of health care products -- Moist heat -- Part 
2: Guidance on the  
12. application of ISO 17665 -1 
13. ISO 11138 -3:2017, Sterilization of health care products -- Biological indicators -
- Part 3: Biological  
14. indicators for moist heat sterilization pro cesses  
15. US Pharmacopoeia 40, 2019  
16. US 1958 -1:2019, Surgical sutures — Specification — Part 1: Absorbable  
17. ISO 10993 (all parts), Biological evaluation of medical devices  
18. ISO 24153 — Random sampling and randomisation procedures  
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_7273_00_e.pdf