Designation

This standard is issued under the fixed designation F624; 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 guide covers the evaluation of thermoplastic polyurethanes in both solid and solution forms for medical applications. The polymers have been reacted to completion and require no further chemical processing.

1.2

The tests and methods listed in this guide may be referenced in specifications containing minimum required values and tolerances for specific end-use products.

1.3

Standard tests for biocompatibility are included to aid in the assessment of safe utilization in medical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the medical device manufacturer must evaluate the biocompatibility of devices that contain the polyurethane of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.

1.4

Material specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific medical end use.

1.5

This standard does not purport to address all of thesafety 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.

1.6

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

4. Significance and Use

4.1

4.2

5. Descriptive Chemical Information

5.1

5.2

5.3

5.4

5.5

5.6

5.7

6. Processing Recommendations

6.1

6.2

6.3

6.4

6.5

6.6

6.7

6.8

6.9

7. Suggested Physical Tests on a Solid Specimen or Film

7.1

7.2

7.3

7.4

7.5

7.6

7.7

7.8

7.9

7.10

7.11

7.12

7.13

7.14

7.15

7.16

7.17

7.18

7.19

8. Suggested Chemical Tests

8.1

8.2

8.3

8.4

8.5

8.6

8.7

8.8

9. Suggested Electrical Tests

9.1

9.2

9.3

9.4

10. Suggested Biological Tests

10.1

10.2

10.3

11. Suggested Testing for Material Stability and Its Impact on Reliability of Products Made of Polyurethane

11.1

12. Suggested Testing for Addressing Materials of Concern

12.1

12.2

13. Packaging, Labeling, and Preservation

13.1

13.2

13.3

14. Keywords

14.1

ASTM F624 - 25

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications

Current

Published:

10 Jun 2025