G/TBT/N/ECU/470  
6 June 2019 
(19-3922) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : ECUADOR  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Servicio Ecuatoriano de Normalización , INEN (Ecuadorian Standardization Service)  
Calle Baquerizo Moreno E8 -29 y Diego de Almagro  
Tel.: (+593 -2) 3825960 to 90  
Website: www.normalizacion.gob.ec  
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:  
Subsecretaría de Calidad  (Under -Secretariat for Qua lity) 
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Foreign Trade, Investment and Fisheries)  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593-2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec ; puntocontactoOTCECU@gmail.com ; 
aramon@produccion.gob.ec ; cyepez@produccion.gob.ec ; jsanchez@produccion.gob.ec  
Website: www.industrias.gob.ec  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 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, wher e applicable) : Other 
breathing appliances and gas masks, excluding protective  
masks having neither mechanical parts nor replaceable filters (HS 9020) ; Other (HS 
392690) ; Other (HS 630790)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Tercera Revisión del Reglamento Técnico Ecuatoriano PRTE I NEN 181  (3R) "Equipos de 
protección respiratoria"  (Draft third revision (3R) of Ecuadorian Standardization Institute 
Technical Regulation PRTE INEN No. 181 "Respiratory protect ive devices") (12 pages, in 
Spanish)  
6. Description of content : The notified Ecuadorian Technical Regulation establishes the 
requirements to be met by respiratory protective devices, prior to the marketing of 
domestic and imported products, with the aim of protecting human health and safety and 
preventing deceptive practices.  
It applies to the following products:  
1. Full face masks for use as respiratory protective equipment;  G/TBT/N/ECU/470  
- 2 - 
  2. Half masks and quarter masks for use as part of respiratory protective equipmen t; 
3. Filtering half masks used as respiratory protective devices;  
4. Particle filters for use as components in unassisted respiratory protective 
equipment;  
5. Gas filters and combined filters used as components in unassisted respiratory 
protective equipment.  
It does not apply to:  
1. Diving, evacuation or escape equipment;  
2. Carbon monoxide filters.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information, labelling ; Prevention of deceptive practices and 
consumer protection ; Protection of human health or safety.  
8. Relevant documents:  
Normative references:  
1. ISO 2859 -1:1999+Amd 1:2011, Sampling procedures for inspection by attributes 
- Part 1 : Sampling schemes indexed by acceptance quality limit (AQL) for lot -by-
lot inspection;  
2. ISO/IEC 17025 :2017, General requirements for the competence of testing and 
calibration laboratories;  
3. ISO/IEC 17050 -1:2004, Conformity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements;  
4. ISO/IEC 17067 :2013, Conf ormity assessment - Fundamentals of product 
certification and guidelines for product certification schemes;  
5. EN 132:1998, Respiratory protective devices - Definitions of terms and 
pictograms;  
6. EN 134:1998, Respiratory protective devices . Nomenclature of comp onents;  
7. EN 136:1998+AC:2003, Respiratory protective devices - Full face masks - 
Requirements, testing, marking;  
8. EN 140:1999+AC:1999, Respiratory protective devices - Half masks and quarter 
masks - Requirements, testing, marking;  
9. EN 143:2000+A1:2006+AC:2005 , Respiratory protective devices - Particle filters 
- Requirements, testing, marking;  
10. EN 149:2001+A1:2009, Respiratory protective devices - Filtering half masks to 
protect against particles - Requirements, testing, marking;  
11. EN 14387:2004+a1:2008, Respiratory protective devices - Gas filter(s) and  
 
combined filter(s) - Requirements, testing, marking;  
12. Código de Regulaciones Federales CFR Título 42 - Salud Pública . PARTE 84: 
Aprobación de dispositivos de protección respiratoria. (2004 -10-01). 
Notification history:  
1. G/TBT/N/ECU/198  
2. G/TBT/N/ECU/198/Add.1  
3. G/TBT/N/ECU/198/Add.2  
4. G/TBT/N/ECU/198/Add.3  
5. G/TBT/N/ECU/198/Add.4  G/TBT/N/ECU/470  
- 3 - 
  9. Proposed date of adoption : 60 days from notification or thereafter  
Proposed date of entry into force : 180 days from the date of adoption  
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:  
Contact and/or National Enquiry Po int: 
Subsecretaría de Calidad  (Under -Secretariat for Quality)  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Foreign Trade, Investment and Fisheries)  
Address : Av. Amazonas entre Unión Nacional de Periodist as y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec ; puntocontactoOTCECU@gmail.com ; 
aramon@produccion.gob.ec ; cyepez@produccion.gob.ec ; jsanchez@produccion.gob.ec  
https://members.wto.org/crnattachments/2019/TBT/ECU/19_3299_00_s.pdf