{"id":198067,"date":"2024-10-19T12:36:35","date_gmt":"2024-10-19T12:36:35","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir77-2018\/"},"modified":"2024-10-25T05:09:48","modified_gmt":"2024-10-25T05:09:48","slug":"aami-tir77-2018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir77-2018\/","title":{"rendered":"AAMI TIR77 2018"},"content":{"rendered":"
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.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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1<\/td>\n | AAMI TIR77:2018; Sorbent-based regenerative hemodialysis systems <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | AAMI Technical Information Report Copyright information <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 1. Scope 1.1 General 1.2 Inclusion 1.3 Exclusion 2 Informative references <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 3 Definitions <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 4 Sorbent-based regenerative hemodialysis systems 4.1 Fundamental elements of sorbent-based regenerative hemodialysis systems <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | Figure 1\u2014Sorbent-based regenerative hemodialysis system (simplified general principle) <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | Figure 2A\u2014Single-pass based hemodialysis system with in-line dialysis fluid preparation Figure 2B\u2014Single-pass based hemodialysis system without in-line dialysis fluid preparation <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 4.2 Use history of sorbent-based regenerative hemodialysis systems 4.3 The REDY hemodialysis system <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 4.4 Historical data from clinical practice <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 5.2.2 Exchange products 5.2.3 Sorbent capacity 5.2.4 Patient medications <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 5.2.5 Uremic solutes <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 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\u2014Validated dialysis fluid delivery system operating from centralized water purification system Figure 4\u2014Validated sorbent-based regenerative hemodialysis system 6.2 ANSI\/AAMI 26772:2014 (Water treatment equipment for hemodialysis and related therapies) <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 6.6 AAMI TIR43 (Ultrapure dialysate for hemodialysis and related therapies) <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | 6.7 ANSI\/AAMI\/IEC 60601-2-16:2012 (Medical electrical equipment \u2013 Part 2-16: particular requirements for basic safety & essential performance of hemodialysis, hemodiafiltration, and hemofiltration equipment) <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR77:2018 – Sorbent-based regenerative hemodialysis systems<\/b><\/p>\n |