値の遡及性

English translation: Traceability of values

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Japanese term or phrase:値の遡及性
English translation:Traceability of values
Entered by: V N Ganesh

19:56 Sep 3, 2008
Japanese to English translations [PRO]
Bus/Financial - Management
Japanese term or phrase: 値の遡及性
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!
Germaine A Hoston
Local time: 10:40
Traceability of values
Explanation:
... 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
Selected response from:

V N Ganesh
Local time: 23:10
Grading comment
Thanks for your timely help!
4 KudoZ points were awarded for this answer



Summary of answers provided
2 +1Traceability of values
V N Ganesh
Summary of reference entries provided
patent_pending
cinefil

  

Answers


15 hrs   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): +1
Traceability of values


Explanation:
... 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

V N Ganesh
Local time: 23:10
Native speaker of: English
PRO pts in category: 4
Grading comment
Thanks for your timely help!

Peer comments on this answer (and responses from the answerer)
agree  patent_pending
1 hr
  -> Thank You.
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Reference comments


3 hrs
Reference

Reference information:
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...

patent_pending
Native speaker of: Native in TetumTetum
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3 hrs
Reference

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


    Reference: http://www.emergogroup.com/files/japan-mhlw-ordinance-169-en...
    Reference: http://www.emergogroup.com/resources/regulations-japan
cinefil
Japan
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 16
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