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血液透析用水優良規範 第一部分:血液透析用水處理設備優良規範

Standards and Recommended Practices for Water in Hemodialysis: Part I: Water Treatment Equipment for Hemodialysis Applications

摘要


血液透析用水品質是非常重要的,因爲在透析治療時,病人血液與透析液在透析器內隔著透析膜進行物質交換,水與透析液的化學組成與微生物含量是血液透析的安全性關鍵。 爲確保透析用水的安全,製造商或供應商應該提供與安裝符合條件的水處理系統且/或水處理個別組件。這些要求條件應遵守國家的、地區的或國際標準的規範。水處理系統在安裝測試合格移交給洗腎單位之後,負責洗腎醫師有責任監督與維持水處理系統性能符合要求條件。 因此,根據AMMI的相關標準規範,全文分成兩個部分,第一部份針對水處理設備的製造商/供應商,第二部份針對監督及維持水處理系統性能的洗腎單位。 本文爲第一部分:血液透析用水處理設備優良規範,係根據AAMI的相關標準,探討與整理水處理系統且/或個別組件的要求條件與其查核。製造商或供應商在供應與安裝時,應證實安裝完成的水處理系統之性能符合要求條件。

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並列摘要


Water plays an important role in the treatment of people who require hemodialysis. During the dialysis process the patient's blood and dialysate are separated only by the dialyzer membrane to exchange solutes and fluid. It is critical that both the water and the dialysate are of safe chemical composition and microbiologic quality. To ensure safe water for dialysis, manufacturer or supplier shall deliver or install water treatment system and/or individual devices complying with the requirements of national, regional or international standards; and the physician in charge of dialysis, the representative of dialysis facility, has the responsibility for maintaining the performance of the system after control of the system has been transferred formally from the installer to the physician. Therefore, in accordance with the AMMI's related standards, two parts are included in this paper to address separately to the manufacturers of water treatment equipment, and to the dialysis facilities with regard to monitoring and maintaining the performance of the water system. This is the first part, water treatment equipment for hemodialysis applications. The requirements and compliance testings of a water treatment system and/or individual devices are discussed in accordance with the AAMI's related standards. The installer of the system has to demonstrate that the performance of the system meets the requirements.

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