G/TBT/N/UGA/1208  
18 May 2020  
(20-3641) 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 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [X], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Medical  face masks; Other instruments and appliances (HS:901890); Other breathing 
appliances and gas masks, excluding protective masks having neither mechanical parts nor 
replaceable filters. (HS:9020); Respiratory protective devices (ICS:13.3 40.30)  
5. Title, number of pages and language(s) of the notified document:  
US EN 14763:2020, Medical face masks — Requirements and test methods, First Edition 
(26 page(s), in English)  
6. Description of content:  This Uganda Standard specifies construction , design, 
performance requirements and test methods for medical face masks intended to limit the 
transmission of infective agents from staff to patients during surgical procedures and other 
medical settings with similar requirements. A medical face mask wi th an appropriate 
microbial barrier can also be effective in reducing the emission of infective agents from the 
nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.  This 
Uganda Standard is not applicable to masks intended exclusiv ely for the personal 
protection of staff.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To control the spread of Coronavirus disease (COVID -19); Consumer 
information, labelling; Prevention of deceptive practices and consumer protection; 
Protection of human health or safety; Quality requirements  G/TBT/N/UGA/1208  
 
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  8. Relevant documents:   
1. EN ISO 10993 -1:2009, B iological evaluation of medical devices — Part 1: Evaluation 
and testing within a risk management process (ISO 10993 -1:2009)  
2. EN ISO 11737 -1:2018, Sterilization of health care products — Microbiological 
methods — Part 1: Determination of a population of microorganisms on products 
(ISO 11737 -1:2018)  
3. ISO 22609:2004, Clothing for protection against infectious agents — Medical face 
masks — Test method for resistance against penetration by synthetic blood (fixed 
volume, horizontally projected)  
4. EN 132, Respiratory protective devices — Definitions of terms and pictograms  
5. EN 149, Respiratory protective devices — Filtering half masks to protect against 
particles — Requirements, testing, marking  
6. EN 1041:2008+A1:2013, Information supplied by the manufac turer of medical 
devices  
7. EN 1174 (all parts), Sterilization of medical devices — Estimation of the population 
of micro -organisms on product  
8. EN ISO 15223 -1:2016, Medical devices — Symbols to be used with medical device 
labels, labelling and information to b e supplied — Part 1: General requirements 
(ISO 15223 -1:2016, Corrected version 2017 -03) 
9. EN ISO 139, Textiles — Standard atmospheres for conditioning and testing 
(ISO 139) 
10. 93/42/EEC Council Directive 93/42/EEC of 14 June 1993 concerning medical 
devices as a mended by Directive 2007/47/EC of the European Parliament and of 
the Council of 5 September 2007  
11. EN ISO 10993 series, Biological evaluation of medical devices (ISO 10993 series)  
9. Proposed date of adoption:  The standard was adopted on 12 May 2020  
Proposed date of entry into force:  The Standard entered into force on 12 May 2020  
10. Final date for comments:  Not applicable  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO TBT National Enquiry Point  
Uganda National Bureau of Standards  
Plot 2 -12 ByPass Link, Bweyogerere Industrial and Business Park  
P.O. Box 6329  
Kampala, U ganda  
Tel: +(256) 4 1733 3250/1/2  
Fax: +(256) 4 1428 6123  
E-mail: info@unbs.go.ug  
Website: https://www.unbs.go.ug