规定血液透析和相关治疗中使用的浓缩物的最低要求。致上述浓缩物的制造商。包括液体和粉末形式的浓缩物。还包括添加剂，也称为尖峰，是可添加到浓缩液中以增加浓缩液中一种或多种现有离子浓度，从而增加最终透析液中一种或多种离子浓度的化学品。给出了在用户设施将酸和碳酸氢盐粉末混合成浓缩物的设备要求。

Specifies minimum requirements for concentrates to be used in haemodialysis and related therapies. Addressed to the manufacturer of such concentrates. Includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. Gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.