G/TBT/N/UGA/1317  
27 April 2021  
(21-3558) 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  
Plot 2 -12 ByPass Link, Bweyogerere Industrial and Business Park  
P.O. Box 6329  
Kampala, Uganda  
Tel: +(256) 4 1733 3250/1/2  
Fax: +(256) 4 1428 6123  
E-mail: info@unbs.go.ug  
Website: https://www.unbs.go.ug  
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 dif ferent 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):  Surgical 
gowns and drapes; Articles of apparel and clothing accessories, incl. gloves, mittens and 
mitts, for all purposes, of vulcanised rubber (excl. hard rubber and footwear and headgear 
and parts thereof) (HS 4015); Surgical instruments an d materials (ICS 11.040.30)  
5. Title, number of pages and language(s) of the notified document:  
DUS 966-1:2021, Surgical clothing — Specification - Part 1: Surgical gowns and drapes, 
Second Edition (18 page(s), in English)  
6. Description of content:  This Draft Uganda Standard specifies requirements, sampling 
and test methods for single -use and reusable surgical gowns and surgical drapes used as 
medical devices for patients, clinical staff and equipment intended to prevent the 
transmission of infective age nts between patients and clinical staff during surgical and 
other invasive procedures. This standard does not apply to incision drapes or films.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, la belling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Quality requirements  G/TBT/N/UGA/1317  
 
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  8. Relevant documents:   
1. G/TBT/N/UGA/221  
2. ISO 22612, Clothing for protection against infectious agents — Test method for 
resistance to dry microbial penetration  
3. ISO 22610, Surgical drapes, gowns and clean air suits, used as medical devices, 
for patients, clinical staff and equipment — Test method to determine the 
resistance to wet bacterial penetration  
4. ISO 11737 -1, Steriliza tion of health care products — Microbiological methods — 
Part 1: Determination of a population of microorganisms on products  
5. ISO 9073 -10, Textiles — Test methods for nonwovens — Part 10: Lint and other 
particles generation in the dry state  
6. ISO 811, Textile s — Determination of resistance to water penetration — 
Hydrostatic pressure test  
7. ISO 13938 -1, Textiles — Bursting properties of fabrics — Part 1: Hydraulic method 
for determination of bursting strength and bursting distension  
8. ISO 9073 -3, Textiles — Test me thods for nonwovens — Part 3: Determination of 
tensile strength and elongation  
9. US ISO 2859 -1, Sampling procedures for inspection  
10. EN 13795 -2:2019, Surgical drapes, gowns and clean air suits, used as medical 
devices for patients, clinical staff and equipment – Part 2: Test methods  
11. ISO 13485:2016, Medical devices — Quality management systems — 
Requirements for regulatory purposes  
12. US 966-1:2011, Medical devices — Surgical gowns, drapes and clean air suits — 
Part 1: General requirements  
13. US 966 -2:2011, Medical devices — Surgical gowns, drapes and clean air suits — 
Part 2: Test methods  
14. US 966 -3:2011, Medical devices — Surgical gowns, d rapes and clean air suits — 
Part 3 Performance requirements  
9. Proposed date of adoption:  December 2021  
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:   
Uganda National Bureau of Standards  
Plot 2 -12 ByPass Link, Bweyogerere Industrial and Business Park  
P.O. Box 6329  
Kampala, Uganda  
Tel: +(256) 4 1733 3250/1/2  
Fax: +(256) 4 1428 6123  
E-mail: info@unbs.go.ug  
Website: https://www.unbs.go.ug  
https://members.wto.org/crnattachments/2021/TBT/UGA/21_3000_00_e.pdf