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AAMI 11663 2014

$75.64

ANSI/AAMI 11663:2014 – Quality of dialysis fluid for hemodialysis and related therapies

Published By Publication Date Number of Pages
AAMI 2014 28
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Specifies minimum quality requirements for dialysis fluids used in hemodialysis and related therapies. Includes dialysis fluids used for hemodialysis and hemodiafiltration, including substitution fluid for hemodiafiltration and hemofiltration.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI 11663:2014, Quality of dialysis fluid for hemodialysis and related therapies
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
8 US deviation to ISO 11663:2014
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
16 4 Requirements
4.1 Microbiological contaminants in dialysis fluid
4.1.1 General
4.1.2 Microbiological requirements for standard dialysis fluid
17 4.1.3 Microbiological requirements for ultrapure dialysis fluid
4.1.4 Microbiological requirements for online prepared substitution fluid
4.2 Chemical contaminants in dialysis fluid
5 Tests for compliance with microbiological requirements
19 Annex A: Rationale for the development and provisions of this International Standard
A.1 Microbiological contaminants in dialysis fluid
20 A.2 Chemical contaminants in dialysis fluid
A.3 Tests for compliance with microbiological requirements
22 Annex B: Reference tables from ISO 13959
Table B.1 — Maximum allowable levels of toxic chemicals and dialysis fluid electrolytes in dialysis watera
23 Table B.2 — Maximum allowable levels of other trace elements in dialysis water
Table B.3 — Analytical test methods for chemical contaminants
26 Bibliography
AAMI 11663 2014
$75.64