DIALYSIS FLUID CHEMICAL COMPOSITION

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-08-2017

Publisher

Association for the Advancement of Medical Instrumentation

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