Designation

This standard is issued under the fixed designation F2459; 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 test method covers the quantitative assessment of the amount of residue obtained from metallic, polymeric, and ceramic medical components when extracted with aqueous or organic solvents.

1.2

This test method does not advocate an acceptable level of cleanliness. It identifies two possible techniques to quantify extractable residue on metallic, polymeric, and ceramic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Other extraction techniques that are considered exhaustive for surface residuals could also be used if validated to ensure the required extraction efficiency.

1.3

Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods.

1.4

The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the suitability for a specific medical component should be demonstrated by validation or study. See Appendix X2.

1.5

This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing, that is, does not intend to satisfy the extractables and leachables requirement of ISO 10993‑18. In addition, this document does not apply to the following medical devices:

1.5.1

Equipment (for example, sterilizers and washers/ washer-disinfectors).

1.5.2

Gas path devices.

1.5.3

Liquid or gaseous medical devices.

1.5.4

Many absorbable medical devices such as hydrogels or naturally occurring derived materials such as collagen, chitin/chitosan, alginic acid, hyaluronic acid, etc. that will be incompatible with the extractions utilized while some absorbable medical devices may be compatible with the method.

1.5.5

Software.

1.5.6

Where other vertical standards exist for specific devices, they will be used in addition to or instead of this standard.

NOTE 1— For extraction of test specimens intended for the biological evaluation of devices or materials, refer to ISO 10993‑12.

1.6

The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7

This standard may involve hazardous or environmentally restricted materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.8

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

2.2

2.3

3. Terminology

3.1

3.2

4. Summary of Test Method

4.1

5. Significance and Use

5.1

5.2

5.3

6. Apparatus

6.1

6.2

6.3

6.4

6.5

6.6

6.7

6.8

6.9

6.10

6.11

6.12

6.13

6.14

6.15

7. Reagents and Materials

7.1

7.2

7.3

8. Hazards

8.1

8.2

9. Sampling, Test Specimens, and Test Units

9.1

9.2

9.3

9.4

9.5

10. Limits of Quantitation and Recovery Efficiency

10.1

10.2

10.3

11. Procedure

11.1

11.2

11.3

11.4

11.5

11.6

11.7

11.8

11.9

11.10

12. Calculation or Interpretation of Results

12.1

12.2

12.3

12.4

13. Additional Analysis

13.1

14. Report

14.1

14.2

15. Precision and Bias

15.1

16. Keywords

16.1

ASTM F2459 - 24

Standard Test Method for Extracting Residue from Medical Components and Quantifying via Gravimetric Analysis

Current

Published:

1 Dec 2024