English term
Certificate of Conformity (COC)
For dissolution testing, the guidelines are specified by the USP, EP and/or JP. This means that all dissolution testers and their accessories must meet the specifications defined in the monograph. These specifications are generally physical and can be measured with the appropriate tools. Thus all baskets, paddles, basket shafts, vessels and any other part of the system should be both defined and measurable within the tolerances specified. All dissolution accessories should conform to these specifications, and the certification that they do so is known as the COC or Certificate of Conformance. The COC generally defines the tolerances that the accessories are manufactured to and these should fall within those defined by the USP. (LabHut)
Certain countries request a CoC for certain categories of imported products. The CoC is sometimes called Certificate of Conformance or Certificate of Compliance. It is generally inspected during customs clearance if the product being imported requires it. Without a CoC, products may be impounded, confiscated, and in some case destroyed. The main reason a CoC is required at customs is to prove a product that the product being imported meets the required standard(s). (Quality Inspection)
Class l devices that are sterile or have a measuring function require the least intervention by a Notified Body before they can be placed on the market. Manufacturers of these devices must have the aspect of metrology, or the process of manufacturing concerned with securing and maintaining sterile conditions audited within the requirements of Annex lV, V or Vl of the Directive. If compliant, the Notified Body issues a certificate of conformance, which allows the manufacturer to compile a declaration of conformity and apply the CE mark to the product. The CE mark must also be accompanied by the Notified Body’s registration number. (Robinson Healthcare)
4 +7 | Certificado de conformidad | Tigranuhi Khachatryan |
3 | Certificado de homologación | walkabout |
Sep 9, 2020 21:47: changed "Kudoz queue" from "In queue" to "Public"
Oct 5, 2020 00:55: changed "Stage" from "Preparation" to "Submission"
Oct 8, 2020 01:56: changed "Stage" from "Submission" to "Completion"
Proposed translations
Certificado de conformidad
La Evaluación de la conformidad de los productos (PCA) de SGS es una solución diseñada para garantizar que los productos cumplen con los requisitos específicos de las normas y regulaciones técnicas establecidas por la autoridad reglamentaria en el país importador. (https://www.sgs.es/es-es/trade/trade-eff)
Certificado de homologación
Si el Estado implicado concluye que una modificación de un expediente de homologación justifica nuevas comprobaciones o pruebas y que, por consiguiente, es necesario modificar el certificado de homologación existente o completar un nuevo certificado de homologación, las autoridades competentes de dicho Estado informarán de ello al fabricante y, en el plazo de un mes a partir de que dichos documentos hayan sido completados, los enviarán a las autoridades competentes de los demás Estados miembros o de Suiza. (BOE)
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