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About This Item
Full Description
This document is applicable to
— the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused.
— the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and
— the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
This document does not apply to
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
This document does not address clinical issues associated with inappropriate usage of such fluids.
Document History
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ISO 23500-1:2024
viewing
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements- Most Recent
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ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements- Historical Version
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ISO 23500:2014
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies- Historical Version
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ISO 23500:2011
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies- Historical Version