AAMI TIR43 2021

$135.70

AAMI TIR43:2021, Ultrapure dialysis fluid for hemodialysis and related therapies

Published By	Publication Date	Number of Pages
AAMI	2021	45

Guaranteed Safe Checkout

Category: AAMI

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Addresses preparation and use of ultrapure fluids to perform hemodialysis. Fluids include water and dialysis fluid. Includes the definition of ultrapure fluids, the rationale for their use, and the means by which they can be prepared. Does not cover peritoneal dialysis fluids.

PDF Catalog

PDF Pages	PDF Title
1	AAMI TIR43:2021; Ultrapure dialysis fluid for hemodialysis and related therapies
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents Page
6	Committee representation
8	Foreword
9	Introduction
11	1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Terms and definitions
12	4 Rationale for the use of ultrapure dialysis fluid 4.1 Exposure to microbiological contaminants in dialysis fluid 4.2 Sources of microbial contamination
13	4.3 Transfer of microbial contaminants across the dialysis membrane and their effect
14	4.4 Benefits associated with use of ultrapure dialysis fluid
15	4.4.1 Nutrition 4.4.2 Amyloidosis
16	4.5 Current status of the use of ultrapure dialysis fluid for dialysis 5 Strategies to achieve ultrapure dialysis fluid 5.1 System design
17	Figure 1 Common system configurations for dialysis water preparation and distribution Table 1 System processes and common technologies used in the production and distribution of dialysis water, fluid concentrates, and dialysis fluids including standard dialysis fluid, ultrapure dialysis fluid and substitution fluid
19	Figure 2 Common system configurations for bicarbonate and acid concentrate preparation and distribution
20	5.2 System validation
21	Figure 3 Example of a validation process for a fluid preparation and distribution system
22	5.3 Basic design considerations
23	5.3.1 Feed water
24	5.3.2 Water treatment system 5.3.3 Chemical quality of dialysis water 5.3.4 Microbial quality of dialysis water 5.3.5 Concentrates and concentrate distribution
25	5.3.6 Dialysis machine 5.3.7 Dialysis fluid quality 5.3.7.1 Standard dialysis fluid quality 5.3.7.2 Ultrapure dialysis fluid quality 5.3.7.3 Substitution fluid quality
26	5.3.7.4 Dialysis fluid filtration to achieve ultrapure dialysis fluid 5.4 Maintenance 5.4.1 System maintenance
27	5.4.2 Pre-treatment component maintenance 5.4.3 Filter maintenance
28	5.5 System cleaning and disinfection 5.5.1 Cleaning 5.5.2 Disinfection
29	5.5.2.1 Disinfection methods 5.5.2.1.1 Physical disinfection methods 5.5.2.1.1.1 Hot water disinfection
30	5.5.2.1.1.2 Ultraviolet light (UV) disinfection 5.5.2.1.2 Chemical disinfectants 5.5.2.1.2.1 Oxidative chemical disinfectants 5.5.2.1.2.2 Peroxyacetic acid (also known as peracetic acid or PAA) 5.5.2.1.2.3 Ozonation
31	5.5.2.1.2.4 Bleach 6 Strategies for reducing biofilm formation
32	6.1 Controlling biofilm 6.2 Biofilm remediation
33	7 Demonstrating compliance with recommendations for the microbial quality of dialysis fluid 7.1 Monitoring bacterial levels
36	7.2 Monitoring endotoxin levels
37	7.3 Monitoring for biofilm 7.4 Recommended monitoring frequencies
39	Bibliography