G/TBT/N/THA/664  
 
21 April 2022  
(22-3186) 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:  THAILAND  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Thai Industrial Standards Institute (TISI), Ministry of Industry  
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:   
WTO/TBT Enquiry Point and Notification Authority  
Thai Industrial Standards Institute (TISI), Ministry of Industry  
Tel.: (662) 430 6831 ext. 2130  
Fax: (662) 354 3041  
E-mail: thaitbt@t isi.mail.go.th  
Website: http://www.tisi.go.th  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other  :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Single -
use hygienic face masks (ICS 11.040.30)  
5. Title, number of pages and language(s) of the notified document:  Draft Ministerial 
Regulation on Single -use hy gienic face masks (TIS  2424–25XX(20XX)); (14 page(s), in 
Thai) 
6. Description of content:  The draft ministerial regulation mandates single -use hygienic 
face masks to conform with the standard for Single -use hygienic face masks (TIS  2424-
25XX(20XX)).  
This standard covers only single -use hygienic face masks used for particle filtration to 
reduce the risk of infectious diseases transmitted through direct person -to-person 
contact.  
The standard does not cover respiratory protective devices: particulate air puri fying (TIS 
2199) and respiratory protective devices: combination particulate and gas and vapour 
(TIS 2382).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/THA/664  
 
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  8. Relevant documents:   
- ASTM F2100 -21 Standard Specification for Performance of Materials Used in Medical 
Face Masks  
- AS 4381 : 2015 Single -use face masks for use in health care  
- ISO 10993 -10 : 2021 Biological evaluation of medical devices — Part 10: Tests or skin 
sensitization  
- ISO 10993 -23 : 2021 Biological evaluation of medical devices — Part 23: Tests for 
irritation  
- TIS 2199 -2547 Respiratory protective devices : particulate air purifying  
- TIS 2382 -2551 Respiratory protective devices : combination particulate and gas and 
vapour  
- TIS 2395 Part 5 -2558 Biological evaluation of medical devices -- Part 5:  Tests for in 
vitro cytotoxicity  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO/TBT Enquiry Point and Notification AuthorityThai Industrial Standards Institute 
(TISI), Ministry of Industry  
Tel.: (662) 430 6831 ext. 2130  
Fax: (662) 354 3041  
E-mail: thaitbt@tisi.mail.go.th  
Website: http://www.tisi.go.th  
 
https:// members.wto.org/crnattachments/2022/TBT/THA/22_2946_00_x.pdf