血液透析及相关治疗用液体的制备和质量管理

[中文适用范围]： 本文件规定了用于血液透析和相关治疗的浓缩液的化学和微生物要求，适用于此类浓缩液的制造商。本文件适用于： — 液体和粉末形式的浓缩液； — 添加剂，也称为加料，是可以添加到浓缩液中的化学物质，用于补充或增加浓缩液中一种或多种现有离子的浓度，从而增加最终透析液中的浓度； — 在用户设施中用于将酸和碳酸氢盐粉末混合到浓缩液中的设备。本文件不适用于： — 在透析设施中用预包装盐和水制备的浓缩液，供该设施使用； — 预包装和无菌透析液； — 再生和再循环少量透析液的吸附剂透析液再生系统； — 执行患者治疗的设备；这在 IEC 60601-2-16 中有所涉及。本文件不涵盖用于临床透析患者的透析液。透析液在 ISO 23500-5 中有规定。透析液的制作包括在床边或中央透析液输送系统中按比例配制浓缩液和水。虽然透析液的标签要求是在浓缩液的标签上，但确保正确使用是用户的责任。 [外文原描述]： This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates. This document is applicable to: — concentrates in both liquid and powder forms; — additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid; — equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. This document does not apply to: — concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility; — pre-packaged and sterile dialysis fluid; — sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid; — equipment to perform patient treatment; this is addressed IEC 60601-2-16. This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.