GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
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23:13 Sep 12, 2005 |
Japanese to English translations [PRO] Medical - Medical (general) / Medical publications | |||||||
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| Selected response from: humbird | ||||||
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ここで言う報告すべき不具合とは、「広く医療機器の具合の良くないこと」をいう。 FYI Explanation: 医療機器 is medical appliances, instruments or equiment, but not medicine. 「広く医療機器の具合の良くないこと」is equal to 「広義での医療機器の不具合」. This implies a failure, defect, malfuntion, erroneous movement and etc. |
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The term "non conformity is defined as ......" Explanation: This, by itself sounds like any medical equipments that does not meet technical criteria. But it is not so. That is why the author has to say 広く. So here is my answer. I don't know non conformity is the best translation for 不具合, but it appears to make sense in the whole sentence. So here is one example. The term non conformity should be read as follows: "Broadly defined, any medical equipment that does not meet specified mode of conformity." 具合の良くない could be malfunctioned, defected, none-meeting to the specifications, etc. However, sentence that follows says 設計、製造、輸入、流通又は使用のいずれの段階によるものであるかを問わない。So, the term 不具合 emcompasses all of these levels, therefore it is not just a technical defect (reason "broadly defined"). Anything that is not meeting the specified requirements are 不具合 in this case, and I believe such requirements are already mentioned in previous sentences. |
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ここで言う報告すべき不具合とは、「広く医療機器の具合の良くないこと」をいう。 Deficiency Explanation: Nonconformity A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate or not according to specified requirements. [From FDA's Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations] Reference: http://www.gmp1st.com/comglos.htm |
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ここで言う報告すべき不具合とは、「広く医療機器の具合の良くないこと」をいう。 The malfunction that should be reported here means "condition of medical machinery is not good in wi Explanation: The malfunction that should be reported here means "condition of medical machinery is not good in wide meaning". 「広く医療機器の具合の良くないこと」is explained to make sounds easy, so, I thought it should sounds easy in english too. |
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ここで言う報告すべき不具合とは、「広く医療機器の具合の良くないこと」をいう。 "Non-conformity to be Reported" refered at this point is "the medical equipment is out of order Explanation: "Non-conformity to be Reported" refered at this point is "the medical equipment is out of order in a broad sense" .....strange, why I have to use parentheses for "Non-conformity to be Reported" ? Anyway I guess what the author want to mean is like this. |
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