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 apparatus 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, excluding 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 902620); Instruments and apparatus for measuring or detecting ionising radiations (HS 903010); Other (HS 940490); Chandeliers and other electric ceiling or wall lighting fittings, excluding those of a kind used for lighting public open spaces or thoroughfares (HS 940510).
Proyecto de Primera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 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)
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.