Preparation and quality management of fluids for haemodialysis and related therapies -- Part 4: Concentrates for haemodialysis and related therapies

Designation Number:
CSA ISO 23500-4
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Sub-Type
Joint Canada-U.S. National Standard
Standard Development Activity:
New Standard
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.

This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer

Project need:

This will meet the strategic needs of the following key interests: a) providing recommendations for the quality of dialysis fluid; b) setting forth quality requirements for the water and concentrates used to prepare dialysis fluid; c) ensuring that dialysis patients have safer water and concentrates used in their treatments; d) protecting healthcare professionals who are responsible for the care of the dialysis patient; e) ensuring that the latest innovative/technology/safety features are available for users, and f) addressing needs of regulators by providing suitable requirements

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.