AAMI RD16 : 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
Hardcopy , PDF
09-03-2010
English
01-01-2007
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 8637:2004
U.S. Deviations to ISO 8637:2004
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Nonpyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
4.4.2 Blood compartment integrity
4.4.3 Hemodialyzer, hemodiafilter, and
hemofilter blood compartment ports
4.4.4 Hemodialyzer or hemodiafilter dialysate
compartment ports
4.4.5 Hemofilter filtrate ports
4.4.6 Hemoconcentrator blood and filtrate ports
4.5 Performance characteristics
4.5.1 Clearance of hemodialyzers and hemodiafilters
4.5.2 Sieving coefficient of hemodiafilters,
hemofilters, and hemoconcentrators
4.5.3 Filtration rate
4.5.4 Volume of the blood compartment
4.5.5 Pressure drop
4.6 Expiration date
5 Test methods
5.1 General
5.2 Biological safety
5.3 Sterility
5.4 Nonpyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity
5.5.2 Blood compartment integrity
5.5.3 Hemodialyzer, hemofilter, and hemodiafilter
blood compartment ports
5.5.4 Hemodialyzer or hemodiafilter dialysate
compartment ports
5.5.5 Hemofilter filtrate ports
5.5.6 Hemoconcentrator blood and filtrate ports
5.6 Performance characteristics
5.6.1 Clearance
5.6.2 Sieving coefficient for hemofilters,
hemodiafilters, and hemoconcentrators
5.6.3 Filtration rate
5.6.4 Volume of the blood compartment
5.6.5 Pressure drop
5.7 Expiration date
6 Labeling
6.1 Labeling on the device
6.2 Labeling on the unit containers
6.3 Labeling on the outer containers
6.4 Accompanying documentation
Annex A (informative) - Rationale for the development
and provisions of this standard
Bibliography
Describes the requirements for hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators hereinafter collectively referred to as "the device," for use for humans.
Committee |
RD
|
DocumentType |
Standard
|
Pages |
44
|
PublisherName |
Association for the Advancement of Medical Instrumentation
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
ISO 8637:2010 | Identical |
ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
15/30290736 DC : 0 | BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
AAMI RD47 : 2008 | REPROCESSING OF HEMODIALYZERS |
EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
BS EN ISO 10993-4:2017 | Biological evaluation of medical devices Selection of tests for interactions with blood |
AAMI RD5 : 2003 | HEMODIALYSIS SYSTEMS |
UNE-EN ISO 10993-4:2018 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
I.S. EN ISO 10993-4:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017) |
ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
AAMI TIR19 : 1998 | GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 8638:2010 | Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
AAMI RD47 : 2008 | REPROCESSING OF HEMODIALYZERS |
ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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