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Certificate of Conformity (COC)

Hungarian translation: Megfelelőségi tanúsítvány

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00:54 Oct 5, 2020
English to Hungarian translations [PRO]
Medical - Medical (general)
Additional field(s): Business/Commerce (general), Science (general), Transport / Transportation / Shipping, Manufacturing, Safety
English term or phrase: Certificate of Conformity (COC)
Definition from IPEC Europe:
A document that confirms that the product shipped to the customer, complies with a specific set of requirements or specifications. It does not contain actual test results.

Example sentence(s):
  • 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
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Question posted on behalf of translation team:
GBK medical and pharma specialistsGBK medical and pharma specialists


This question is closed

Hungarian translation:Megfelelőségi tanúsítvány
Definition:
A megfelelőségi tanúsítvány a hatóságok és a vásárlók részére igazolja, hogy a termék teljesíti a rá vonatkozó követelményeket. A gyártó – vagy a termék Európai Unión belüli első forgalmazója – a megfelelőségi tanúsítvány aláírásával személyesen felelősséget vállal aziránt, hogy a termék teljesíti a rá vonatkozó követelményeket.
Selected response from:

Katalin Horváth McClure
United States
Grading comment
4 KudoZ points were awarded for this answer



Summary of translations provided
5 +2Megfelelőségi tanúsítvány
Katalin Horváth McClure


Discussion entries: 2





  

Translations offered


4 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +2
Megfelelőségi tanúsítvány


Definition from Piac & Profit:
A megfelelőségi tanúsítvány a hatóságok és a vásárlók részére igazolja, hogy a termék teljesíti a rá vonatkozó követelményeket. A gyártó – vagy a termék Európai Unión belüli első forgalmazója – a megfelelőségi tanúsítvány aláírásával személyesen felelősséget vállal aziránt, hogy a termék teljesíti a rá vonatkozó követelményeket.

Example sentence(s):
  • Megfelelőségi Tanúsítványaink (CoC) a nemzetközileg elismert minőségbiztosítási/ellenőrzési folyamatainkra támaszkodnak. - SGS  
  • A CoC (megfelelőségi tanúsítvány) fontos dokumentum az irányelvek hatálya alá tartozó termékek CE-jelölése szempontjából, és az EN szabványoknak való megfelelés fontos a tanúsítvány megszerzéséhez. - TÜR CERT  
  • A megfelelőségi tanúsítvány (más néven COC-igazolás, COC-dokumentum vagy COC-papír) az Európai Közösség-típusjóváhagyással való megfelelőségi nyilatkozat. - Atrium Automobile  

Explanation:
REGULATION (EU) 2017/745 on medical devices

EN: (62) It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity.

HU:(62) Célszerű, hogy a szabadforgalmi igazolásokban szerepeljen olyan információ, amely lehetővé teszi az Eudamed használatát annak érdekében, hogy tájékozódni lehessen az eszközről, különösen arról, hogy az eszköz piaci forgalomban van-e, kivonták-e a forgalomból vagy visszahívták-e, továbbá a megfelelőségére vonatkozó tanúsítványokról.
Katalin Horváth McClure
United States
Local time: 02:09
Native speaker of: Native in HungarianHungarian
PRO pts in category: 82

Votes in favor of/against selecting this as the best translation of the term asked
Yes  Erzsébet Czopyk
16 hrs
Yes  Sándor Hamvas
2 days 22 hrs
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