臨牀透析 Vol.23 No.5(1-2)


特集名 透析液清浄化技術の最前線
題名 透析液清浄化基準 (2) 海外の最近の動向
発刊年月 2007年 05月
著者 酒井 良忠 日本医療器材工業会人工腎臓部会ISO担当委員
【 要旨 】 透析液水質管理に関するIS0 23500はなお審議中であり,その成立は2009年末頃に遅れる見込みである.各国はISOの動きとは別に国内基準を作成または改訂を盛んに進めている.本邦では,実情掌握と改善対策の検討が遅れていると思われるが,ISOの成立が遅れている間にこれらの検討を進め,日本からもISOに盛り込む意見を出していく必要がある.
Theme The Front of Dialysate Purification Technologies in Hemodialysis Therapy
Title Recent foreign trends in water quality management for dialysis
Author Yoshitada Sakai Japan Medical Devices Manufacturers Association, Division of Artificial Kidney, Committee member for ISO
[ Summary ] The ISO 23500 standard, which is a dialysate quality management criteria, is now being discussed. More time than expected has been spent on this discussion. Finalization of this work is expected by the end of 2009. Foreign countries have actively settled on or revised their own standards individually, presumably by considering the discussions of the ISO working group. It seems that confirmation of real situations of water quality management and finding ways to improve them has been delayed in Japan by each dialysis unit and manufacturer. The Japanese medical community should contribute their opinions if some different points to be included in the ISO standards are discovered during the next two years of the study.
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