AAMI TIR72 : 2017
Current
The latest, up-to-date edition.
DIALYSIS FLUID CHEMICAL COMPOSITION
Hardcopy , PDF
English
08-09-2017
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Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Definitions
3 Rationale for the control of chemical
composition of dialysis fluid
4 Strategies to achieve control of chemical
content in dialysis fluid
5 Example of dialysis product process flow
diagram
Bibliography
Describes the roles of manufacturing, laboratory testing, and clinical processes in relation to the production and testing of dialysis fluid for hemodialysis.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-695-5
|
| Pages |
25
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| AAMI 13959 : 2014 | WATER FOR HEMODIALYSIS AND RELATED THERAPIES |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| AAMI 11663 : 2014 | QUALITY OF DIALYSIS FLUID FOR HEMODIALYSIS AND RELATED THERAPIES |
| AAMI 26722 : 2014 | WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS AND RELATED THERAPIES |
| AAMI 13958 : 2014 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
| ANSI/AAMI/IEC 60601-1-2:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| AAMI IEC 60601-2-16 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT |
| AAMI 23500 : 2014 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES |
| ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| AAMI RD52 : 2004 | DIALYSATE FOR HEMODIALYSIS |
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