G/TBT/N/SLV/209  
15 September  2020 
(20-6174) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : EL SALVADOR  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Organismo Salvadoreño de Reglamentación Técnica , OSARTEC 
(Salvadoran Technical Regulation Agency)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regardin g the notification shall be indicated if different from above:  
Ministerio de Economía  (Ministry of the Economy)  
Dirección de Administración de Tratados Comerciales  (Directorate for the Administration 
of Trade Agreements)  
Alameda Juan Pablo II y Calle Guadalupe , Plan Maestro, San Salvador, El Salvador  
Website: http://www.minec.gob.sv  
Tel.: (+503) 2590 5788  
Fax: (+503) 2590 578 9 
Email: datco@minec.gob.sv  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 5.6.2 [ ], 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) : Health 
care technology ( ICS 11 ) 
5. Title, number of pages and language(s) of the notified document : Reglamento 
Técnico Salvadoreño RTS 11 .03.01:20, Insumos médicos . Mascarillas de uso médico . 
Especificaciones técnicas y métodos de ensayo  (Salvadoran Technical Regulation RTS 
11.03.01:20, Medical inputs . Face masks for medical use . Technical specifications and 
test methods) (9 pages, in Spanish)  
6. Description of content : The notified Regulation establishes technical requirements 
(including test methods) for the safety, quality and effectiveness of face masks for 
medical use.  
It applies to all domestically manufactured and imported face masks for medical use that 
are marketed in national territory  and used to limit the transmission of infectious agents 
from medical staff to patients and other individuals during surgical procedures and in 
other medical settings with similar requirements . The text sets out technical specifications 
in respect of produ ct design ; quality, safety and performance requirements ; and test 
methods.  
Face masks for non -medical use or those that do not meet the specific characteristics 
described are excluded from the scope of the Technical Regulation . G/TBT/N/SLV/209  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable : In view of the COVID -19 pandemic, steps are being taken to prevent a 
shortage of face masks, which are required to prevent and control the disease, and to 
maintain the level of supply necessary for medical and hospital staff nationwide, thus 
enabling the State to adopt and mainta in measures to protect and preserve human life 
and health ; Protection of human health or safety.  
8. Relevant documents:  
• 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).  
• UNE-EN 14683:2019+AC Medical face masks . Requirements and test methods . 
• Ley de Medicamentos . Dirección Nacional de Medicamentos . Decreto Legislativo 
No 1008, Diario Oficial No. 43, Tomo No. 394 del  2 de marzo de 2012 . El 
Salvador.  
• Reglamento General de la Ley de Medicamentos . Dirección Nacional de 
Medicamentos . Decreto Legislativo No . 245, Diario Oficial No. 239, Tomo No. 
397 del 20 de diciembre de 2012 . El Salvador.  
9. Proposed date of adoption : 15 July 2 020 
Proposed date of entry into force : 16 July 2 020 
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:  
Ministerio de Economía  (Ministry of the Economy)  
Dirección de Administración de Tratados Comerciales  (Directorate for the Administration 
of Trade Agreements)  
Alameda Juan Pablo II y Calle Guadalupe Plan Maestro, San Salvador, El Salvador  
Website: http://www.minec.gob.sv  
Tel.: (+503) 2590 5788  
Fax: (+503) 2590 5789  
Email: datco@minec.gob.sv  
 
Consejo Nacional de Calidad  (National Quality Council)  
Organismo Salvadoreño de Reglamentación Técnica , OSARTEC (Salvadoran Technical 
Regulation Agency)  
Boulevard San Bartolo y Calle Lempa, costado Norte del INSAFORP, Edificio CNC, 
Ilopango, San Salvador, El Salvador  
Website: http://www.osartec.gob.sv  
Tel.: (+503) 2590 5335 ; (+503) 2590 5338  
Email: consultasreglamento@osartec.gob.sv