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AAMI ISO 10993-4 : 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD

Available format(s)

Hardcopy , PDF

Superseded date

02-01-2018

Language(s)

English

Published date

01-01-2009

€136.39
Excluding VAT

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-4
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood (as categorized
  in ISO 10993-1)
  5.1 Non-contact devices
  5.2 External communicating devices
  5.3 Implant devices
6 Characterization of blood interactions
  6.1 General requirements
  6.2 Categories of tests and blood interactions
      6.2.1 Recommended tests for interactions of devices
            with blood
      6.2.2 Non-contact devices
      6.2.3 External communicating devices
      6.2.4 Implant devices
      6.2.5 Indications and limitations
  6.3 Types of tests
      6.3.1 In vitro tests
      6.3.2 Ex vivo tests
      6.3.3 In vivo tests
Annexes
A - Preclinical evaluation of cardiovascular devices and
    prostheses
B - Laboratory tests-Principles, scientific basis, and
    interpretation
C - Evaluation of hemolytic properties of medical devices
    and their components
Bibliography
Tables
Figure

Describes general requirements for evaluating the interactions of medical devices with blood.

Committee
WG 09
DocumentType
Standard
Pages
48
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO 10993-4:2017 Identical

AAMI BF7 : 2012 BLOOD TRANSFUSION MICROFILTERS
AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE
ASTM F 2888 : 2013 Standard Test Method for Platelet Leukocyte Count—An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials

ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
CFR 29(PTS1900-1910) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
NFS 90 300 : 1981
BS 5736-11:1990 Evaluation of medical devices for biological hazards Method of test for haemolysis
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 3826:1993 Plastics collapsible containers for human blood and blood components
AAMI CVP3 : 1981 CARDIAC VALVE PROSTHESES
ISO 7199:2016 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
AAMI VP20 : 2ED 94 CARDIOVASCULAR IMPLANTS - VASCULAR GRAFT PROSTHESES
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN 58361-4:1980-09 TRANSFUSION, INFUSION, TRANSFUSION CONTAINERS AND ACCESSORIES, PLASTIC CONTAINERS FOR BLOOD, REQUIREMENTS, TESTS, SUPERVISION AND LABELLING
ISO 5841-1:1989 Cardiac pacemakers Part 1: Implantable pacemakers

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