AAMI RD5 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
HEMODIALYSIS SYSTEMS
Hardcopy , PDF
10-14-2010
English
01-01-2008
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Glossary of equivalent standards
Committee representation
Foreword
1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Normative references
3 Definitions
4 Requirements
4.1 Labeling
4.1.1 Device markings
4.1.2 Descriptive labeling
4.2 Alarm systems
4.2.1 Deaeration system
4.2.2 Back-siphon protection from the drain
4.2.3 Water system backflow protection
4.2.4 Monitors and alarms for dialysate systems and blood
circuits
4.3 Other features and monitoring accessories
4.4 Safety requirements
4.4.1 General safety requirements
4.4.2 Electrical safety requirements
4.4.3 Electromagnetic compatibility requirements
4.4.4 Fluid contact compatibility
5 Tests
5.1 Labeling
5.2 Alarm systems
5.2.1 Deaeration system
5.2.2 Back-siphon protection from the drain
5.2.3 Water system backflow protection
5.2.4 Monitors and alarms for dialysate systems and
blood circuits
5.3 Other features and monitoring accessories
5.4 Safety requirements
5.4.1 General safety requirements
5.4.2 Electrical safety requirements
5.4.3 Electromagnetic compatibility requirements
5.4.4 Fluid contact compatibility
Annexes
A - Rationale for the development and provisions of
this standard
Bibliography
Specifies apparatus for preparing dialysate, monitors of the dialysate, and accessories for monitoring the extracorporeal blood circuit.
| Committee |
RD
|
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| UNE-EN ISO 13959:2016 | Water for haemodialysis and related therapies (ISO 13959:2014) |
| AAMI RD52 : 2004 : R2010 | DIALYSATE FOR HEMODIALYSIS |
| AAMI RD52 : 2004 | DIALYSATE FOR HEMODIALYSIS |
| DIN EN ISO 13959:2016-03 | WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014) |
| BS ISO 13959 : 2014 | WATER FOR HAEMODIALYSIS AND RELATED THERAPIES |
| AAMI RD47 : 2008 | REPROCESSING OF HEMODIALYZERS |
| 13/30270471 DC : 0 | BS ISO 13959 - WATER FOR HAEMODIALYSIS AND RELATED THERAPIES |
| BS EN ISO 13959:2015 | Water for haemodialysis and related therapies |
| I.S. EN ISO 13959:2015 | WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014) |
| 17/30321199 DC : 0 | BS EN ISO 23500-3 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 3: WATER FOR HAEMODIALYSIS AND RELATED THERAPIES |
| AAMI 13959 : 2014 | WATER FOR HEMODIALYSIS AND RELATED THERAPIES |
| ISO 13959:2014 | Water for haemodialysis and related therapies |
| EN ISO 13959:2015 | Water for haemodialysis and related therapies (ISO 13959:2014) |
| AAMI RD62 : 2006 | WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS |
| AAMI ISO 13959 : 2009 | WATER FOR HEMODIALYSIS AND RELATED THERAPIES |
| AAMI RD52 : 2004 : INC : AMD 1 : 2007 : AMD 2 : 2007 : AMD 3 : 2009 : AMD 4 : 2009 | DIALYSATE FOR HEMODIALYSIS |
| CFR 29(PTS1900-1910) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| ISO 8637:2010 | Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| CFR 29(PTS1920-END) : 1986 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| AAMI RD17 : 2007 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| AAMI SP10 : 2002 | MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS |
| AAMI RD16 : 2007 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
| AAMI RD62 : 2006 | WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS |
| AAMI RD61 : 2006 | CONCENTRATES FOR HEMODIALYSIS |
| 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 ES1 : 3ED 93 | SAFE CURRENT LIMITS FOR ELECTROMEDICAL APPARATUS |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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