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AAMI RD5 : 2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

HEMODIALYSIS SYSTEMS
Available format(s)

Hardcopy , PDF

Superseded date

14-10-2010

Language(s)

English

Published date

01-01-2008

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Superseded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
DIN EN ISO 13959 E : 2016 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014)
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
IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
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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