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."

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."
Entered by: humbird

23:13 Sep 12, 2005
Japanese to English translations [PRO]
Medical - Medical (general) / Medical publications
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。
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.
Troy Fowler
United States
Local time: 11:50
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.
Selected response from:

humbird
Grading comment
Thanks humbird. That was a big help.
4 KudoZ points were awarded for this answer



Summary of answers provided
4The term "non conformity is defined as ......"
humbird
3FYI
ishigami
3Deficiency
snowbees
2The malfunction that should be reported here means "condition of medical machinery is not good in wi
MICHIRU YABU
1"Non-conformity to be Reported" refered at this point is "the medical equipment is out of order
Kazumichi Sato (X)


  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
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.

ishigami
Local time: 02:50
Native speaker of: Native in JapaneseJapanese
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
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.

humbird
Native speaker of: Native in JapaneseJapanese, Native in EnglishEnglish
PRO pts in category: 8
Grading comment
Thanks humbird. That was a big help.
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3 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
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
snowbees
Local time: 03:50
Native speaker of: Native in JapaneseJapanese
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4 hrs   confidence: Answerer confidence 2/5Answerer confidence 2/5
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.

MICHIRU YABU
Japan
Local time: 03:50
Native speaker of: Native in JapaneseJapanese
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5 hrs   confidence: Answerer confidence 1/5Answerer confidence 1/5
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.


Kazumichi Sato (X)
Japan
Local time: 03:50
Specializes in field
Native speaker of: Japanese
PRO pts in category: 12
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