G/TBT/N/ECU/488  
26 June 2020 
(20-4445) 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:  
puntocontacto -OTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@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) : Orthopaedic 
or fracture appliances (HS 902110) ; Appliances which are worn or carried, or implanted in 
the body, to compensate for a defect or disability (excluding artificial parts of the body, 
hearing aids and pacemakers) (HS 902190)  
5. Title, number of pages and language(s) of the notified document : Proyecto del 
Reglamento Técnico Ecuatoriano PRTE I NEN 262  "Productos de apoyo para caminar"  (Draft 
Ecuadorian Technical Regulation PRTE INEN No. 262 "Assistive products for walking") (12 
pages, in Spanish)  
6. Description of content : The notified Ecuadorian Technical Regulation establishes the 
requirements to be met by assistive products for walking, prior to the marketing of 
domestic and imported products, with the aim of protecting human health and safety and 
preventing deceptive practi ces. 
It applies to the following products:  G/TBT/N/ECU/488  
- 2 - 
  • Walking frames;  
• Rollators;  
• Walking tables;  
• Elbow crutches fully equipped with handgrip and tip, and specified for a user weight 
of not less than 35 kg;  
• Walking sticks with three or more legs, fully equipped with h andle and tips, and 
specified for a weight of not less than 35 kg.  
It does not apply to:  
• Walking sticks with three or more legs with underarm or forearm support;  
• Walking chairs.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : 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 9999 :2016, Assistive products for persons with disability - Classification and 
terminology;  
3. ISO 11199 -1:1999, Walking aids manipulated by both arms - Requirements and test 
methods - Part 1 : Walking frames;  
4. ISO 11199 -2:2005, Walking aids manipulated by both arms - Requirements and test 
methods - Part 2 : Rollators;  
5. ISO 11199 -3:2005, Walking aids manipulated by both arms - Requirements and test 
methods - Part 3 : Walking tables;  
6. ISO 11334 -1:2007, Assistive products for walking manipulated by one arm - 
Requirements and test methods - Part 1 : Elbow crutches;  
7. ISO 11334 -4:1999, Walking aids manipulated by one arm  - Requirements and test 
methods - Part 4 : Walking sticks with three or more legs;  
8. ISO 13485 :2016, Medical devices - Quality management systems - Requirements for 
regulatory purposes;  
9. ISO/IEC 17025 :2017, General requirements for the competence of testing and 
calibration laboratories ; 
10. ISO/IEC 17050 -1:2004, Conformity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements;  
11. ISO/IEC 17067 :2013, Conformity assessment - Fundamentals of product 
certification and guidelines for product certif ication schemes;  
12. EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical 
devices;  
13. Sanitary Technical Regulation ARCSA -DE-026-2016-YMIH:2016 , Normativa técnica 
sanitaria sustitutiva para el registro sanitario y control de dispositivos médi cos de 
uso humano, y de los establecimientos en donde se fabrican, importan, dispensan, 
expenden y comercializan . 
Notification history:  
1. G/TBT/N/ECU/316  G/TBT/N/ECU/488  
- 3 - 
  9. Proposed date of adoption : 60 days from the date of notification  
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  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca  (MPCEIP)  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontacto -OTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
www.normalizacio n.gob.ec  
 
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