Glossary entry (derived from question below)
Japanese term or phrase:
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。
English translation:
"Broadly defined, any medical equipment that does not meet specified mode of conformity."
Added to glossary by
humbird
Sep 12, 2005 23:13
18 yrs ago
1 viewer *
Japanese term
United States
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。
Japanese to English
Medical
Medical (general)
Medical publications
From a terms definition document between two medical suppliers. This is the first sentence of a definition for "non-conformity report". Here is the entire section.
===============
*不具合報告(nonconformity report)
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。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。（平成9年3月27日 薬発第421号）
不具合の種類としては、
副作用
製品仕様上の問題
...
...
===============
I don't understand the 1st sentence. Any help?
Thank you.
===============
*不具合報告(nonconformity report)
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。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。（平成9年3月27日 薬発第421号）
不具合の種類としては、
副作用
製品仕様上の問題
...
...
===============
I don't understand the 1st sentence. Any help?
Thank you.
Proposed translations
(English)
Proposed translations
1 hr
Selected
The term "non conformity is defined as ......"
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.
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.
4 KudoZ points awarded for this answer.
Comment: "Thanks humbird. That was a big help."
1 hr
Japanese term (edited):
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FYI
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.
「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.
3 hrs
Japanese term (edited):
�����Ō������ׂ��s��Ƃ́A�u�L����Ë@��̋�̗ǂ��Ȃ����Ɓv����B
Deficiency
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]
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:
4 hrs
Japanese term (edited):
�����Ō������ׂ��s��Ƃ́A�u�L����Ë@��̋�̗ǂ��Ȃ����Ɓv����B
The malfunction that should be reported here means "condition of medical machinery is not good in wi
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.
「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.
5 hrs
Japanese term (edited):
�����Ō������ׂ��s��Ƃ́A�u�L����Ë@��̋�̗ǂ��Ȃ����Ɓv����B
"Non-conformity to be Reported" refered at this point is "the medical equipment is out of order
"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.
.....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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