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AAMI RD16 : 2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS

Available format(s)

Hardcopy , PDF

Superseded date

09-03-2010

Superseded by

AAMI ISO 8637 : 2010

Language(s)

English

Published date

01-01-2007

US$103.00
Excluding Tax where applicable

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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