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Certificate of Conformity (COC)

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00:54 Oct 5, 2020
English to Croatian 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 will remain open until an answer receives the required level of agreement from peers. Submission is still possible.


Summary of translations provided
5 +1Potvrda o sukladnosti
Andrej Furlan


  

Translations offered


3 days 9 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +1
Potvrda o sukladnosti


Definition from ADESA:
potvrda o sukladnosti (COC) isprava je kojom se potvrđuje da je vaše vozilo usklađeno s normama EZ-a i može se slobodno kretati na području Europske unije.

Example sentence(s):
  • Potvrda o sukladnosti (COC) najjednostavniji je put do prijave uvezenog vozila u Hrvatskoj, ali i u drugim zemljama diljem Europe, jer sadrži sve tehničke podatke o vozilu, kao npr. visinu emisija, vrstu guma, podatke o motoru itd. - EuroCoc  
  • Na zahtjev magistara farmacije, Hrvatska ljekarnička komora izdaje: Potvrdu o sukladnosti obrazovanja magistra farmacije s Direktivom 2005/36/EZ - Hrvatska ljekarnička komora  
Andrej Furlan
Slovenia
Local time: 07:47
Native speaker of: Croatian
PRO pts in category: 4

Votes in favor of/against selecting this as the best translation of the term asked
Yes  bonafide1313
57 days
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