BS EN ISO 23500-4:2024 - Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies

Standard Number: BS EN ISO 23500-4:2024

Pages: 32

Released: 2024-04-24

ISBN: 978 0 539 20679 1

Status: Standard

Overview

The BS EN ISO 23500-4:2024 standard is an essential document for professionals involved in the preparation and quality management of fluids for haemodialysis and related therapies. This comprehensive standard provides detailed guidelines and requirements to ensure the highest quality and safety of concentrates used in haemodialysis treatments.

Why Choose BS EN ISO 23500-4:2024?

Haemodialysis is a critical therapy for patients with renal failure, and the quality of the fluids used in this process is paramount. The BS EN ISO 23500-4:2024 standard offers a robust framework to ensure that these fluids meet stringent quality and safety criteria. By adhering to this standard, healthcare providers can significantly reduce the risk of complications and improve patient outcomes.

Key Features

• Comprehensive Guidelines: The standard provides detailed instructions on the preparation and quality management of haemodialysis fluids, ensuring that all aspects of the process are covered.
• Safety and Quality Assurance: By following the guidelines in this standard, healthcare providers can ensure that the fluids used in haemodialysis are safe and of high quality.
• International Recognition: As an ISO standard, BS EN ISO 23500-4:2024 is recognized globally, making it a valuable resource for healthcare providers around the world.
• Up-to-Date Information: Released in 2024, this standard includes the latest advancements and best practices in the field of haemodialysis.

Detailed Content

The BS EN ISO 23500-4:2024 standard spans 32 pages and covers a wide range of topics related to the preparation and quality management of haemodialysis fluids. Some of the key areas covered include:

• Preparation of Concentrates: Detailed procedures for the preparation of haemodialysis concentrates, including the selection of raw materials and the mixing process.
• Quality Control: Guidelines for the quality control of haemodialysis fluids, including testing methods and acceptable limits for various contaminants.
• Storage and Handling: Best practices for the storage and handling of haemodialysis concentrates to ensure their safety and efficacy.
• Documentation and Record-Keeping: Requirements for documentation and record-keeping to ensure traceability and accountability in the preparation and use of haemodialysis fluids.

Benefits of Compliance

Compliance with the BS EN ISO 23500-4:2024 standard offers numerous benefits for healthcare providers and patients alike:

• Enhanced Patient Safety: By ensuring that haemodialysis fluids meet stringent quality and safety standards, healthcare providers can reduce the risk of adverse reactions and complications.
• Improved Treatment Outcomes: High-quality haemodialysis fluids contribute to more effective treatments and better patient outcomes.
• Regulatory Compliance: Adhering to this internationally recognized standard helps healthcare providers meet regulatory requirements and avoid potential legal issues.
• Increased Trust and Credibility: Compliance with the BS EN ISO 23500-4:2024 standard demonstrates a commitment to quality and safety, enhancing the trust and credibility of healthcare providers.

Who Should Use This Standard?

The BS EN ISO 23500-4:2024 standard is designed for a wide range of professionals involved in the preparation and quality management of haemodialysis fluids, including:

• Healthcare Providers: Hospitals, clinics, and other healthcare facilities that offer haemodialysis treatments.
• Pharmaceutical Manufacturers: Companies that produce haemodialysis concentrates and related products.
• Regulatory Authorities: Organizations responsible for overseeing the quality and safety of medical products and treatments.
• Quality Assurance Professionals: Individuals responsible for ensuring the quality and safety of haemodialysis fluids.

Conclusion

The BS EN ISO 23500-4:2024 standard is an invaluable resource for anyone involved in the preparation and quality management of fluids for haemodialysis and related therapies. By providing comprehensive guidelines and best practices, this standard helps ensure the highest levels of safety and quality in haemodialysis treatments, ultimately leading to better patient outcomes and enhanced trust in healthcare providers.

Invest in the BS EN ISO 23500-4:2024 standard today and take a significant step towards improving the quality and safety of haemodialysis treatments in your facility.

BS EN ISO 23500-4:2024

This standard BS EN ISO 23500-4:2024 Preparation and quality management of fluids for haemodialysis and related therapies is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics
• 11.120.99 Other standards related to pharmaceutics

This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates. This document is applicable to: —     concentrates in both liquid and powder forms; —     additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid; —     equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. This document does not apply to: —     concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility; —     pre-packaged and sterile dialysis fluid; —     sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid; —     equipment to perform patient treatment; this is addressed IEC 60601-2-16. This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.