Condoms - Natural rubber latex male condoms, male synthetic condoms, female condoms

Incorpora los productos que indica al régimen de control sanitario establecido en el Artículo 111 del Código Sanitario y en el Decreto Supremo N° 825 de 1998 del Ministerio de Salud (Incorporation of the indicated products into the health control system established in Article 111 of the Health Code and in Ministry of Health Supreme Decree No. 825 de 1998) (3 pages, in Spanish)

The notified text incorporates the indicated products for medical use into the health system established in Article 111 of the Health Code and the regulations thereto, approved by Ministry of Health Supreme Decree No. 825. The conformity of such products must be verified in accordance with the following technical standards and specifications:

Preservativos - Condones Masculinos de Látex de Caucho Natural: Norma ISO-UNE EN 4074: 2016, Clase III (Condoms - Natural rubber latex male condoms: Standard ISO-UNE EN 4074: 2016, Class III);

ISO 23409:2011, Male condoms - Requirements and test methods for condoms made from synthetic materials, Class III; ISO 25841:2017, Female condoms - Requirements and test methods, Class III.