BS EN ISO 23500-1:2024 - Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies General Requirements

Standard Number: BS EN ISO 23500-1:2024

Pages: 116

Released: 2024-09-04

ISBN: 978 0 539 20657 9

Status: Standard

Overview

The BS EN ISO 23500-1:2024 standard is a comprehensive guide dedicated to the preparation and quality management of fluids used in haemodialysis and related therapies. This essential document outlines the general requirements necessary to ensure the safety, efficacy, and quality of fluids used in these critical medical treatments.

Key Features

• Comprehensive Coverage: Spanning 116 pages, this standard provides an in-depth look at the various aspects of fluid preparation and quality management, ensuring that all necessary protocols and guidelines are thoroughly covered.
• Up-to-Date Information: Released on September 4, 2024, this document includes the latest advancements and best practices in the field, making it an invaluable resource for healthcare professionals and facilities.
• Global Standard: As an ISO standard, it is recognized and respected worldwide, ensuring that the guidelines provided are of the highest quality and applicable across different regions and healthcare systems.
• ISBN: 978 0 539 20657 9, ensuring easy reference and cataloging for libraries and institutions.

Why This Standard is Essential

Haemodialysis is a life-saving procedure for patients with kidney failure, and the quality of fluids used in this process is paramount. The BS EN ISO 23500-1:2024 standard provides a detailed framework for the preparation and management of these fluids, ensuring that they meet the highest safety and quality standards. This is crucial for preventing complications and ensuring the best possible outcomes for patients.

Who Should Use This Standard?

This standard is designed for a wide range of professionals and organizations, including:

• Healthcare Providers: Ensuring that the fluids used in haemodialysis meet the required standards is essential for patient safety and treatment efficacy.
• Medical Device Manufacturers: Companies involved in the production of haemodialysis equipment and fluids will find this standard invaluable for ensuring their products meet international quality and safety standards.
• Regulatory Bodies: Government and regulatory agencies can use this standard to develop and enforce regulations related to haemodialysis fluids.
• Academic and Research Institutions: Researchers and educators can use this standard as a reference for studies and training programs related to haemodialysis and fluid management.

Detailed Content

The BS EN ISO 23500-1:2024 standard covers a wide range of topics, including but not limited to:

• Specifications for water quality used in haemodialysis
• Guidelines for the preparation of dialysis fluid
• Quality control measures and testing protocols
• Maintenance and monitoring of fluid preparation systems
• Safety and risk management procedures
• Documentation and record-keeping requirements

Benefits of Adopting This Standard

Adopting the BS EN ISO 23500-1:2024 standard offers numerous benefits, including:

• Enhanced Patient Safety: By adhering to the guidelines, healthcare providers can significantly reduce the risk of complications associated with haemodialysis fluids.
• Improved Treatment Outcomes: High-quality fluids contribute to more effective haemodialysis treatments, leading to better patient outcomes.
• Regulatory Compliance: Meeting the requirements of this standard helps organizations comply with national and international regulations, avoiding potential legal and financial penalties.
• Operational Efficiency: Clear guidelines and protocols streamline the preparation and management of haemodialysis fluids, improving overall operational efficiency.
• Reputation and Trust: Adopting internationally recognized standards enhances the reputation of healthcare providers and manufacturers, building trust with patients and stakeholders.

Conclusion

The BS EN ISO 23500-1:2024 standard is an indispensable resource for anyone involved in the preparation and quality management of fluids for haemodialysis and related therapies. Its comprehensive guidelines ensure the highest standards of safety and quality, ultimately leading to better patient care and treatment outcomes. Whether you are a healthcare provider, medical device manufacturer, regulatory body, or academic institution, this standard provides the essential information and protocols needed to excel in the field of haemodialysis fluid management.

BS EN ISO 23500-1:2024

This standard BS EN ISO 23500-1:2024 Preparation and quality management of fluids for haemodialysis and related therapies is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment
• 11.040.40 Implants for surgery, prosthetics and orthotics
• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis 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. 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.