G/TBT/N/UGA/1318  
27 April 2021  
(21-3559) 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 
clean air suits; 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 and  materials (ICS 11.040.30)  
5. Title, number of pages and language(s) of the notified document:  
DUS 966-2:2021, Surgical clothing — Specification - Part 2: Clean air suits, Second 
Edition (18 page(s), in English)  
6. Description of content:  This Draft Ugan da Standard specifies requirements, sampling 
and test methods for single -use and reusable surgical clean air suits used as medical 
devices for patients, clinical staff and equipment intended to prevent the transmission of 
infective agents between patients and clinical staff during surgical and other invasive 
procedures. It does not apply to scrub suits.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices an d 
consumer protection; Protection of human health or safety; Quality requirements  G/TBT/N/UGA/1318  
 
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  8. Relevant documents:   
1. G/TBT/N/UGA/220  
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, Sterilization of health care products — Microbiol ogical 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, Textiles — 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 methods for nonwovens — Part 3: Determinat ion of 
tensile strength and elongation  
9. ISO 11607 (all parts), Packaging for terminally sterilized medical devices  
10. US ISO 10993, Biological evaluation of medical devices  
11. EN13795 -2_2019, Surgical clothing and drapes — Requirements and test 
methods — Part 2 C lean air suits  
12. ISO 13485:2016, Medical devices — Quality management systems — 
Requirements for regulatory purposes  
13. US 966 -1:2011, Medical devices — Surgical gowns, drapes  and clean air suits — 
Part 1: General requirements  
14. US 966 -2:2011, Medical devices — Surgical gowns, drapes and clean air suits, — 
Part 2: Test methods  
15. US 966 -3:2011, Medical devices — Surgical gowns, drapes and clean air suits, - 
Part 3 Performance requir ements  
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 63 29 
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_3001_00_e.pdf