ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 87
- Дата публикации:
- 15 февраля 2019 г.
- Издание:
- ISO IS 23500 edition 1 version 1
- ICS:
- 11.040.40
1.1 General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice. This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies. The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments. 1.2 Inclusions This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of this document, dialysis fluid includes: a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid, b) dialysis water used for the preparation of concentrates at the user's facility, c) concentrates, d) the final dialysis fluid and substitution fluid. The scope of this document includes a) 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, b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. 1.3 Exclusions 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.
Abstract
Overview
ISO 23500-1:2019 - Preparation and quality management of fluids for haemodialysis and related therapies (Part 1: General requirements) is the base standard of the ISO 23500 series. It provides recommended practice and guidance for the preparation, quality oversight and safe use of fluids used in haemodialysis, haemodiafiltration, haemofiltration and related therapies. The standard covers dialysis water, concentrates, final dialysis fluid and online-prepared substitution fluid, and defines the user's responsibilities for these fluids once water-treatment and proportioning equipment have been installed.
Keywords: ISO 23500-1:2019, dialysis fluid, dialysis water, haemodialysis, water treatment, substitution fluid, quality management.
Key Topics
- Scope and applicability: Defines inclusions (dialysis water, concentrates, final dialysis and substitution fluids) and exclusions (sorbent-based regeneration systems, CRRT with pre‑packaged solutions, peritoneal dialysis).
- Quality requirements: Framework for chemical and microbiological quality management of dialysis water, concentrates and final dialysis fluid.
- System design considerations: Critical aspects of water treatment and distribution system design, technical and microbiological design principles, and environmental impact.
- Validation and qualification: Validation planning, installation and operational qualification (IQ/OQ), performance qualification (PQ), routine surveillance and revalidation requirements.
- Surveillance and monitoring: Ongoing monitoring of water treatment equipment, storage and distribution systems, concentrates, proportioning units and dialysis fluid quality; record retention expectations.
- Microbiological control strategies: Disinfection principles, disinfection frequency, sampling methods, heterotrophic plate counts, bacterial endotoxin testing and fungal surveillance.
- Practical guidance: Annexes provide rationale, equipment guidance, surveillance procedures, validation examples and special considerations for home and acute haemodialysis.
Applications
ISO 23500-1 is practical for:
- Dialysis practitioners and clinical teams responsible for daily fluid quality and therapy safety decisions.
- Clinical engineers and facility managers overseeing water-treatment systems, storage and distribution.
- Medical device and water-treatment vendors designing, delivering or commissioning dialysis fluid preparation equipment.
- Quality and infection-control staff implementing surveillance, disinfection programs and validation protocols.
Use cases include establishing a dialysis water quality program, validating a new reverse-osmosis/distribution system, setting surveillance schedules, documenting disinfection and record-retention procedures, and defining responsibilities for concentrate preparation and proportioning.
Related Standards
ISO 23500-1 is the foundational part of the ISO 23500 series. Other parts address specific equipment and fluid types (ISO 23500-2 to ISO 23500-5, renumbered from earlier related standards). Consult the full ISO 23500 series for detailed product and method-specific requirements.
Технические детали
- Технический комитет
- ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
- SKU
- ISO 23500-1:2019
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