ANSI/AAMI/RD61-2006 pdf download.Concentrates for hemodialysis.
For the purpose of this standard,“concentrates" are a mixture of chemicals and water, or a mixture of chemicals in the form of dry powder, that are delivered to the end user to make dialysate used to perform hemodialysis. This standard is addressed to the manufacturer of such concentrates. In several instances in this standard, it became necessary to address the dialysate, which is made by the end user, to help clarity the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysate, any reference to dialysate is for clarification and is not a requirement on the manufacturer. The requirements and goals established by this standard will help ensure the effective, safe performance of hemodialysis concentrates and related materials.
1.2 Inclusions This standard includes bicarbonate and acid concentrates in both liquid and powder forms. Also included are additives commonly calld "spikes," chemicals which may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysate. This standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
1.3 Exclusions Although references to dialysate appear herein, this standard does not address dialysate. Also excluded from the scope of this standard are requirements for monitoring the purity of water used for mixing concentrate at a dialysis facility. The recommendations of this committee for monitoring water quality are contained in ANSI/AAMI RD52:2004, Dialysate for hemodialysis. Also, this standard does not address bags of sterile dialysate.
2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. AAMI maintains a register of currently valid AAMI technical documents.
2.1 AMERICAN PUBLIC HEALTH ASSOCIATION. Standard Methods for the Examination of Water and Wastewater. (20th ed.). Washington, DC: APHA, 1995.
2.2 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Water treatment equipment for hemodialysis applications (ANSIVAAMI RD62:2006). Arlington (VA): AAMI, 2006. 2.3 U.S. ENVIRONMENTAL PROTECTION AGENCY. Methods for Chemical Analysis of Water and Waste (EPA- 600-4-79-020). Cincinnati (OH): Environmental Research Center, Environmental Monitoring and Support Laboratory, 1979 (Revised March 1983).
2.4 UNITED STATES PHARMACOPEIA. United States Pharmacopeia -National Formulary (USP 28-NF 23). Rockville (MD): United States Pharmacopeial Convention Inc, 2003.
2.5 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION Dialysate for hemodialysis ANSIAAMI RD52:2004, Arlington (VA): AAMI, 2004.
2.6 UNDERWRITERS LABORATORIES. Satety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use- Part 1: General Requirements. UL-61010-1, Northbrook (IL): UL, 2004.ANSI/AAMI/RD61 pdf download.