Glossary entry

Japanese term or phrase:

値の遡及性

English translation:

Traceability of values

Added to glossary by V N Ganesh
Sep 3, 2008 19:56
15 yrs ago
Japanese term

値の遡及性

Japanese to English Bus/Financial Management
This is a document with government requirements governing the production of medical equipment, but this section has to do with quality control. Here is the complete sentence:
診断用医療機器の性能が較正器又は標準物質の使用に依存している場合、これらの較正器又は標準物質に割り当てられている値の遡及性は、品質管理システムを通して保証しなければならない。

Could this be "retraceability of the value" allotted to these other elements? Any help would be greatly appreciated!
Proposed translations (English)
2 +1 Traceability of values
Change log

Mar 23, 2010 16:33: V N Ganesh Created KOG entry

Mar 23, 2010 16:33: V N Ganesh changed "Edited KOG entry" from "<a href="/profile/119615">V N Ganesh's</a> old entry - "値の遡及性"" to ""Traceability of values""

Proposed translations

+1
15 hrs
Selected

Traceability of values

... of values assigned to calibrators and control materials, 体外診断医療機器- 生物試料中の定量測定-校正子と対照物質に付与された値の測定学的な遡及性 ...
www2u.biglobe.ne.jp/~standard/bdlist/ks/ksp.htm - 337k
Peer comment(s):

agree patent_pending
1 hr
Thank You.
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4 KudoZ points awarded for this answer. Comment: "Thanks for your timely help!"

Reference comments

3 hrs
Reference:

6.1 Traceability
Traceability of measurement is ensured when there is an unbroken chain of comparisons of equipment known uncertainty which link one measurement result to the next and eventually to a national standard
measurement (and therefore to the SI system). Each link in the chain compares equipment with reference equipment of the same or (usually) smaller uncertainty and may involve reference artefacts or materials.
The concept of traceability also includes the competence of all the people involved, the fitness measurement environment, the suitability of the methods used and all other aspects of the quality technical systems involved at each step in the chain of measurements.
Traceability must be established for all critical* measurement and calibration equipment either:
http://www.ianz.govt.nz/publications2/pdfs/as_lab_c3_electri...
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3 hrs
Reference:

couldn't find the English version of MHLW Notification #112 of 2005 so far
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