AAMI BE78 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY
Hardcopy , PDF
04-09-2010
English
01-01-2008
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Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-10:2002 and
rationale for minor technical deviation
ANSI/AAMI deviation from ISO 10993-10:2002
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles-Step-wise approach
5 Pretest considerations
5.1 General
5.2 Types of material
5.2.1 Initial considerations
5.2.2 Ceramics, metals, and alloys
5.2.3 Polymers
5.2.4 Biologically derived materials
5.3 Information on chemical composition
5.3.1 General
5.3.2 Existing data sources
5.4 Material characterization
6 Irritation tests
6.1 In vitro irritation tests
6.2 Factors to be considered in design and selection
of in vivo tests
6.3 Animal skin irritation test
6.3.1 Principle
6.3.2 Test material
6.3.3 Animals and husbandry
6.3.4 Test procedure
6.3.5 Observation of animals
6.3.6 Evaluation of results
6.3.7 Test report
6.4 Human skin irritation test
6.4.1 Introduction
6.4.2 Initial considerations
6.4.3 Principle
6.4.4 Description of the method
6.4.5 Data and reporting
7 Delayed hypersensitivity tests
7.1 Choice of test
7.2 Choice of test sample concentrations
7.2.1 General
7.2.2 Induction
7.2.3 Challenge
7.3 Other important factors affecting the
outcome of the test
7.4 Maximization test for delayed hypersensitivity
7.4.1 Principle
7.4.2 Test sample preparation
7.4.3 Animals and husbandry
7.4.4 Test procedure
7.4.5 Observation of animals
7.4.6 Evaluation of results
7.4.7 Test report
7.5 Closed-patch test for delayed hypersensitivity
7.5.1 Principle
7.5.2 Test sample preparation
7.5.3 Animals and husbandry
7.5.4 Test procedure
7.5.5 Observation of animals
7.5.6 Evaluation of results
7.5.7 Test report
8 Key factors in interpretation of test results
Annexes
A Preparation of materials for irritation/sensitization
testing
B Additional irritation tests
C Background information
Bibliography
Defines the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.
| Committee |
WG 08
|
| DocumentType |
Standard
|
| Pages |
57
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 10993-10:2010 | Identical |
| ASTM F 2407 : 2006 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| ASTM F 2407 : 2006 : R2013 : EDT 1 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| AAMI BF64 : 2012 | LEUKOCYTE REDUCTION FILTERS |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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