Certificate of Conformity (COC)

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00:55 Oct 5, 2020

英語から日本語への翻訳 [PRO]
Medical - 医療(一般)
追加欄: ビジネス/商業(一般), 科学(一般), 輸送/運送/海運, 製造, Safety

英語の用語またはフレーズ Certificate of Conformity (COC)

定義：より 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.

例文：

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 specialists

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提案された訳語の一覧

5 +1

適合証

Agnishwar Choudhury

提案された訳語

12時間自信度：

ピアによる賛成(ネット数)： +1

適合証

定義：より goo net:
国が認めた指定自動車整備事業者が車両を検査し、保安基準に適合していると判断した場合に業者側が発行することができる書面を、保安基準適合証と言います。

例文：

車検の際に、指定自動車整備事業者であるディーラーや整備工場での車検が終わり、保安基準に適合している証として交付されるものに、保安基準適合証と保安基準適合標章が存在します。 - goo net
保安基準適合証を運輸局に提出することで、審査を受けることができます。 - goo net
二第四十一条第二項の規定により交付した設計基準適合証の写し。 - 個人研究

説明：
定義として書きしてありますもの具体的ですけれども、一般的な定義はないと思っています。

文字通り、基準等に適合していることの証明書。

「適合証明書」が用いられる場合もありますが、「適合証」が用いられている場合はるかに多いというふうに考えております。

Agnishwar Choudhury
インド
Local time: 14:35
母国語：英語

回答者へのメモ

Akihiko Takeda 適合証明曙とした方が適合そのものを証明した書類ということで、より明確です。適合証だけだとはっきり証明しているかどうかが不明瞭です。

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