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AAMI TIR77 2018

AAMI TIR77 2018

$93.55

AAMI TIR77:2018 – Sorbent-based regenerative hemodialysis systems

Published By Publication Date Number of Pages
AAMI 2018 31
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Provides useful technical information that addresses common aspects pertaining to development and use of sorbent-based regenerative hemodialysis systems and a review of existing hemodialysis standards within the context of sorbent-based regenerative hemodialysis systems.

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PDF Pages PDF Title
1 AAMI TIR77:2018; Sorbent-based regenerative hemodialysis systems
3 Title page
4 AAMI Technical Information Report
Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
9 Foreword
10 Introduction
11 1. Scope
1.1 General
1.2 Inclusion
1.3 Exclusion
2 Informative references
12 3 Definitions
13 4 Sorbent-based regenerative hemodialysis systems
4.1 Fundamental elements of sorbent-based regenerative hemodialysis systems
14 Figure 1—Sorbent-based regenerative hemodialysis system (simplified general principle)
15 Figure 2A—Single-pass based hemodialysis system with in-line dialysis fluid preparation
Figure 2B—Single-pass based hemodialysis system without in-line dialysis fluid preparation
16 4.2 Use history of sorbent-based regenerative hemodialysis systems
4.3 The REDY hemodialysis system
17 4.4 Historical data from clinical practice
18 4.5 Sorbent-based dialysis fluid regeneration processes
5 Informative guidance for developers and users: Common aspects of sorbent-based regenerative hemodialysis systems
5.1 Source water
19 5.1.1 Source water specification
5.1.2 Source water control
5.2 Dialysis fluid composition
5.2.1 General considerations for sorbent-based regenerative hemodialysis systems
21 5.2.2 Exchange products
5.2.3 Sorbent capacity
5.2.4 Patient medications
22 5.2.5 Uremic solutes
23 6 Sorbent-based regenerative hemodialysis systems in context of hemodialysis standards
6.1 ANSI/AAMI 23500:2014 (Guidance for the preparation and quality management of fluids for hemodialysis and related therapies)
Figure 3—Validated dialysis fluid delivery system operating from centralized water purification system
Figure 4—Validated sorbent-based regenerative hemodialysis system
6.2 ANSI/AAMI 26772:2014 (Water treatment equipment for hemodialysis and related therapies)
24 6.3 ANSI/AAMI 13959:2014 (Water for hemodialysis and related therapies)
6.4 ANSI/AAMI 13958 (Concentrates for hemodialysis and related therapies)
6.5 ANSI/AAMI 11663:2014 (Quality of dialysis fluid for hemodialysis and related therapies)
25 6.6 AAMI TIR43 (Ultrapure dialysate for hemodialysis and related therapies)
26 6.7 ANSI/AAMI/IEC 60601-2-16:2012 (Medical electrical equipment – Part 2-16: particular requirements for basic safety & essential performance of hemodialysis, hemodiafiltration, and hemofiltration equipment)
28 Bibliography
AAMI TIR77 2018
$93.55