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AAMI TIR72
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AAMI TIR72 2017 Edition, January 1, 2017 Dialysis fluid chemical composition
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Description / Abstract:
This TIR addresses the roles of manufacturing, laboratory testing, and clinical processes in relation to the production and testing of dialysis fluid for hemodialysis.
Inclusions
The TIR includes discussion of the roles, processes and materials involved in the preparation and use of dialysis fluids for hemodialysis and strategies for managing the risk of failures occurring in related process steps.
Exclusions
This TIR does not cover peritoneal dialysis fluids, prepackaged fluids, such as those used in continuous renal replacement therapies (CRRT), or sorbent-based dialysis fluid systems that regenerate and recirculate small volumes of dialysis fluid. Although microbiologic contamination is a critical component of dialysis fluid quality, it is addressed in existing standards and therefore not included in this document.
Inclusions
The TIR includes discussion of the roles, processes and materials involved in the preparation and use of dialysis fluids for hemodialysis and strategies for managing the risk of failures occurring in related process steps.
Exclusions
This TIR does not cover peritoneal dialysis fluids, prepackaged fluids, such as those used in continuous renal replacement therapies (CRRT), or sorbent-based dialysis fluid systems that regenerate and recirculate small volumes of dialysis fluid. Although microbiologic contamination is a critical component of dialysis fluid quality, it is addressed in existing standards and therefore not included in this document.