涵盖用于处理用于血液透析和相关治疗的饮用水的设备，包括用于在透析设施中从粉末或其他高浓度介质制备浓缩物的水；透析液的制备，包括可用于制备替代液的透析液；在允许多次使用的情况下，对一次性使用的透析器进行再处理，以及对未明确标记为一次性使用的透析器进行再处理。

Covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; the reprocessing of dialysers intended for single use where permitted for multiple uses, and the reprocessing of dialysers not specifically marked as intended for single use.