G/TBT/N/ECU/469  
6 June 2019 
(19-3897) 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, where applicable) : 854310 
Particle accelerators ; Mechano -therapy appliances ; massage apparatus ; psychological 
aptitude -testing apparatus ; ozone therapy, oxygen therapy, aerosol therapy, artificial 
respiration or other therapeutic  respiration apparatus (HS 9019) ; Other breathing 
appliances and gas masks, excluding protective masks having neither mechanical parts 
nor replaceable filters (HS 9020);  Parts and accessories (not specified or included 
elsewhere in this Chapter) for machines, appliances, instruments or ap paratus of Chapter 
90 (HS 9033) ; Medical, surgical, dental or veterinary furniture (for example, operating 
tables, examination tables, hospital beds with mechanical fittings, dentists' chairs) ; 
barbers' chairs and similar chairs, having rotating as well as  both reclining and elevating 
movements ; parts of the foregoing articles (HS 9402) ; Particle accelerators (HS 85431) ; 
Electro -diagnostic apparatus (including apparatus for functional exploratory examination 
or for checking physiological parameters) (HS 90181);  Ultra-violet or infra -red ray 
apparatus (HS 901820) ; Other (HS 901849) ; Other ophthalmic instruments and 
appliances (HS 901890) ; Hearing aids, excluding parts and accessories (HS 902140) ; 
Pacemakers for stimulating heart muscles, ex cluding parts and accessories (HS 902150) ; 
Computed tomography apparatus (HS 902212) ; Other, for dental uses (HS 902213) ; 
Other, for medical, surgical or veterinary uses (HS 902214);  For medical, surgical, dental 
or veterinary uses (HS 902221) ; X-ray tubes  (HS 902230) ; Other, including parts and 
accessories (HS 902290) ; Other (HS 902519) ; For measuring or checking pressure (HS G/TBT/N/ECU/469  
- 2 - 
  902620) ; Instruments and apparatus for measuring or detecting ionising radiations (HS 
903010) ; Other (HS 940490) ; Chandeliers and ot her electric ceiling or wall lighting 
fittings, excluding those of a kind used for lighting public open spaces or thoroughfares 
(HS 940510).  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Primera Revisión del Reglamento Té cnico Ecuatoriano PRTE I NEN 186  (1R) "Equipos y 
sistemas electromédicos"  (Draft first revision (1R) of Ecuadorian Technical Regulation 
PRTE INEN No. 186 "Electro -medical equipment and systems") (16 pages, in Spanish)  
6. Description of content : The notified Ecuadorian Technical Regulation establishes the 
requirements to be met by electro -medical equipment and systems, 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:  
• Electro -medical equipment and electro -medical systems (including "applicable 
parts") for human use (see Annex 1).  
It does not apply to:  
• Implantable parts of active implantable medical devices covered by ISO 14708 -
1. 
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information, labelling ; Prevention of deceptive practices and 
consumer protectio n; 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 14708 -1:2014, Implants for surgery -- Active implantable medical devices -
- Part 1 : General requirements for safety, marking and for information to be 
provided by the manufacturer;  
3. ISO 80601 , Medical electrical equipment (all parts);  
4. ISO/IEC 17025 :2017, General requirements for the competence of testing and 
calibration laboratories;  
5. ISO/IEC 17050 -1:2004, Conformity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements;  
6. ISO/IEC 17067 :2013, Conformity assessment - Fundamentals of product 
certification and guidelines for product certification schemes;  
7. IEC 60601 -1:2006, Medical electrical equipment . Part 1: General requirements 
for basic safety and essential performance . And the referenc ed collateral 
standards;  
8. IEC 60601 , Medical electrical equipment (all parts);  
9. IEC 80601 , Medical electrical equipment (all parts);  
10. ARCSA -DE-026-2016-YMIH:2016, Normativa técnica sanitaria sustitutiva para el 
registro sanitario y control de dispositivos méd icos de uso humano, y de los 
establecimientos en donde se fabrican, importan, dispensan, expenden y 
comercializan . 
Notification history:  
1. G/TBT/N/ECU/238  G/TBT/N/ECU/469  
- 3 - 
  2. G/TBT/N/ECU/238/Add.1  
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 Point:  
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 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  
www.normalizacion.gob.ec  
https://members.wto.org/crnattachments/2019/TBT/ECU/19_3298_00_s.pdf