G/TBT/N/ECU/197  
27 February 2014  
(14-1195)  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: ECUADOR 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible:  
Instituto Ecuatoriano de Normalización, INEN (Ecuadorian Standardization Institute) 
Calle Baquerizo Moreno E8-29 y Diego de Almagro Tel.: +593 2 250-1885 Fax: +593 2 256-7815 
Email: puntocontactoOTCECU@mipro.gob.ec  
Website: http://www.inen.gob.ec/  
Name and address (including telephone and fax numbers and 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 la Calidad  (Under-Secretariat for Quality) 
Ministerio de Industrias y Productividad , MIPRO (Ministry of Industry and Productivity) 
Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador Tel.: +593 2 394-8760, Ext. 2358 
Email: aanrango@mipro.gob.ec ; mmartinez@mipro.gob.ec ; 
PuntocontactoOTCECU@mipro.gob.ec  
Website: http://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): 
8419.89.99 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
PRTE INEN 180 "Esterilizadores y equipos de lavado y desinfección" (Draft Technical 
Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 180: "Sterilizers and washing and disinfection equipment") (5 pages, in Spanish)  
6. Description of content: The notified draft Technical Regulation covers the following: 
Purpose; Scope; Definitions; Requirements; Test methods; Labelling requirements; 
Reference documents; Conformity assessment procedure; Monitoring and inspection 
authority; Penalty regime; Liability of conformity assessment bodies; and Review and Updating. G/TBT/N/ECU/197 
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified Technical Regulation lays down the safety requirements for 
electrical equipment for sterilizing, washing and disinfecting medical materials in the 
medical, veterinary, pharmaceutical and laboratory sectors. 
It applies to the following domestically manufactured and imported products marketed in 
Ecuador: 
Sterilizers and equipment that disinfect using steam; 
Sterilizers and equipment that disinfect using toxic gas, toxic aerosols or toxic steam; Sterilizers and equipment that disinfect using hot air or hot inert gas; 
Washing equipment that disinfects. 
It does not apply to the following products: Equipment for use in hazardous gas atmospheres (see International Electrotechnical 
Commission (IEC) Standard 60079), except for atmospheres created inside equipment 
through the use of an inflammable sterilizing agent; 
Environmental chambers (see IEC Standard 61010-1); Laboratory equipment for the heating of materials for non-sterilizing and non-disinfecting 
purposes (see IEC Standard 61010-2-010); 
Washing equipment (see IEC Standard 60335, Parts 2-4, 2-7 and 2-11, and International 
Organization for Standardization (ISO) Standard 10472), unless designed for disinfecting 
medical materials; 
Dishwashers (see IEC Standard 60335, Parts 2-5 and 2-58). 
8. Relevant documents:  
1. Publication where notice appear s: http://www.industrias.gob.ec/, 
 http://www.inen.gob.ec/ ; 
2. Proposal and basic document: Proyecto de PRTE INEN 180 "Esterilizadores y 
equipos de lavado y desinfección" (Draft Technical Regulation of the Ecuadorian 
Standardization Institute (PRTE INEN) No. 180: "Sterilizers and washing and 
disinfection equipment"); 
3. Publication in which Technical Regula tion will be published when adopted: Registro 
Oficial  (Official Journal).  
9. Proposed date of adoption: 
 
Proposed date of entry into force:   90 days from 14 February 2014. 
Six months after adoption.  
10. Final date for comments: 15 May 2014 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body: Contact 
and/or National Enquiry Point: 
Subsecretaría de la Calidad 
Ministerio de Industrias y Productividad, MIPRO 
Yánez Pinzón N26-12, entre Av. Colón y La Niña 
Quito, Ecuador Tel.: +593 2 394-8760, Ext. 2358 or 2253 
Email: aanrango@mipro.gob.ec ; mmartinez@mipro.gob.ec ; 
puntocontactoOTCECU@mipro.gob.ec 
Website: http://www.industrias.gob.ec/