This standard is issued under the fixed designation F749; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

1. Scope

1.1

This practice is an intracutaneous reactivity test used to assess the potential of the material under test to produce irritation following intradermal injections of extracts of the material.

1.2

The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.

1.3

This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.

1.4

The values stated in SI units, including units officially accepted for use with the SI, are to be regarded as standard. No other systems of measurement are included in this standard.

1.5

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

2.1 ASTM Standards:2

3. Summary of Practice

3.1

4. Significance and Use

4.1

4.2

4.3

5. Apparatus

5.1 Cages

5.2 Syringes

6. Test Animals

6.1 Rabbits

7. Sampling

7.1

8. Sample and Test Specimen

8.1

8.2

9. Procedure

9.1 Preparation of Rabbits

9.2

9.3

9.4

10. Interpretation of Results

10.1

10.2 Retest Conditions

10.3

11. Report

11.1

11.2

11.3

12. Keywords

12.1

ASTM F749 - 20

Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

Current

Published:

1 Feb 2020

1. Scope