SIST EN ISO 23500-4:2024 PDF

Overview

SIST EN ISO 23500-4:2024, published by CEN, is an internationally recognized standard providing comprehensive requirements for the preparation and quality management of concentrates for haemodialysis and related therapies. This standard outlines the chemical and microbiological requirements for manufacturers of concentrates used in haemodialysis, covering both liquid and powder forms, additives/spikes, and equipment used to mix acid and bicarbonate powders at the user's facility.

The purpose of SIST EN ISO 23500-4:2024 is to ensure safety, consistency, and effectiveness in the products used for the generation of dialysis fluids, thus directly supporting patient wellbeing and the reliability of haemodialysis treatments.

Key Topics

This standard addresses several vital areas:

• Product Scope:

  • Concentrates in liquid and powder forms for haemodialysis.
  • Additives ("spikes") used to adjust ion concentrations in the final dialysate.
  • Equipment employed to mix powders into concentrates within healthcare settings.

• Chemical Requirements:

  • Definition of allowable concentrations and tolerances for ions (e.g., sodium, potassium, calcium).

• Microbiological Requirements:

  • Validation of processes to limit microbial and endotoxin contamination.
  • Special conditions for bicarbonate-based and acid-based concentrates.

• Manufacturing and Packaging:

  • Material compatibility for equipment in contact with concentrates.
  • Requirements for containers and closures to prevent contamination and maintain product integrity.

• Labelling:

  • Specific labelling requirements for both liquid and powder concentrates, as well as additives and concentrate generators.
  • Clear responsibility instructions for users regarding the safe and proper use of concentrates and generated dialysis fluid.

• Exclusions:

  • The standard does not cover concentrates prepared from pre-packaged salts and water on-site, pre-packaged and sterile dialysis fluids, sorbent regeneration systems, or dialysis machines themselves.

Applications

SIST EN ISO 23500-4:2024 plays a critical role in the healthcare sector, particularly within dialysis centers and facilities providing renal replacement therapies. Key applications include:

• Manufacturing:

  • Guiding manufacturers of haemodialysis concentrates to meet international safety and performance criteria.
  • Ensuring that facilities involved in the bulk mixing or preparation of concentrates use compatible materials and validated equipment.

• Healthcare Providers:

  • Assisting dialysis units and technicians in selecting approved and standardized products.
  • Supporting staff training on correct mixing practices and product labelling, reducing risks to patients.

• Quality and Regulatory Compliance:

  • Providing a benchmark for compliance with both European and global regulatory bodies.
  • Supporting internal quality management systems and audits in facilities producing or using haemodialysis concentrates.

• Product Development:

  • Facilitating innovation in the formulation of concentrates, including new additives, by providing clarity on required documentation and validation.

Related Standards

To ensure cohesive quality management within haemodialysis and related therapies, SIST EN ISO 23500-4:2024 should be used in conjunction with the following standards:

• EN ISO 23500-1: General requirements for the preparation and quality management of fluids for haemodialysis and related therapies.
• EN ISO 23500-3: Water requirements for haemodialysis.
• EN ISO 23500-5: Quality requirements for dialysis fluid.
• IEC 60601-2-16: Specific requirements for safety and essential performance of haemodialysis equipment.
• IEC 61010-1: Safety requirements for electrical equipment used in laboratory and measurement settings.

Adherence to SIST EN ISO 23500-4:2024 ensures the highest standards in the production and handling of concentrates for haemodialysis, contributing to safer patient care and effective clinical practices in renal therapies.