ASTM F3014-14

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures (Withdrawn 2023)

SIGNIFICANCE AND USE
5.1 This test method provides a means of assessing the penetration force of a surgical needle through the chosen media.  
5.2 The needle is passed through a chosen medium at a chosen speed and path which applies a force on the load cell that reflects the needle’s resistance to penetration as a function of its shape and coating.
SCOPE
1.1 This test method describes the procedure for penetration testing sharp and blunt needles used for the placement of surgical sutures. It only describes the test procedures (Phase 1) and does not define a test medium at this time. Test media will be address in the next phase (Phase 2) of this test method’s evolution.  
1.2 This test method applies to straight and curved surgical needles.  
1.3 This test method does not intend to address the value of the test with respect to actual conditions of use.  
1.4 In this test method, it is assumed the needles used for this test have passed all applicable quality standards and have no physical malformation that would inappropriately influence the test results.  
1.5 This test method quantifies the force required for a needle to pass through a medium and its ability to do so multiple times.  
1.6 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.7 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 and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This test method described the procedure for penetration testing sharp and blunt needles used for the placement of surgical sutures.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this test method was withdrawn in July 2023 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Withdrawn
• Publication Date: 28-Feb-2014
• Withdrawal Date: 09-Jul-2023
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3014 − 14
Standard Test Method for
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Penetration Testing of Needles Used in Surgical Sutures
This standard is issued under the fixed designation F3014; 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 (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The purpose of this test method is to provide a common method for fixturing and measuring the
penetration force of a surgical needle. Most surgical needles are coated to facilitate passage through
tissue. This coating needs to be both lubricious and durable. The lubricity of the coating acts to lower
the penetration force, while the durability of the coating maintains the needle’s ability to pass through
tissue multiple times with minimum increase in penetration force. It has been observed that, when a
coating is found to be more lubricious, that coating is often less durable. Likewise, when a coating is
found to be more durable, that coating is often less lubricious. Comparative measurements of lubricity
and durability can provide an expectation of how the coated needle may perform during actual use.
This standard does not presently address the testing medium. Test medium will be addressed in the
next phase of this test method development. However, this test method does require certain medium
characteristics to be identified.
1. Scope Combining values from the two systems may result in noncon-
formance with the standard.
1.1 This test method describes the procedure for penetration
1.7 This standard does not purport to address all of the
testing sharp and blunt needles used for the placement of
safety concerns, if any, associated with its use. It is the
surgical sutures. It only describes the test procedures (Phase 1)
responsibility of the user of this standard to establish appro-
and does not define a test medium at this time. Test media will
priate safety and health practices and determine the applica-
be address in the next phase (Phase 2) of this test method’s
bility of regulatory limitations prior to use.
evolution.
1.2 This test method applies to straight and curved surgical
2. Referenced Documents
needles.
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2.1 ASTM Standards:
1.3 This test method does not intend to address the value of
E122 Practice for Calculating Sample Size to Estimate, With
the test with respect to actual conditions of use.
Specified Precision, the Average for a Characteristic of a
Lot or Process
1.4 In this test method, it is assumed the needles used for
F1840 Terminology for Surgical Suture Needles
this test have passed all applicable quality standards and have
no physical malformation that would inappropriately influence
3. Terminology
the test results.
3.1 Definitions—Terms used in this test method are in
1.5 This test method quantifies the force required for a
accordance with Terminology F1840.
needle to pass through a medium and its ability to do so
3.2 Definitions of Terms Specific to This Standard:
multiple times.
3.2.1 compound curved surgical needle, n—needle having
1.6 Units—The values stated in either SI units or inch-
more than one radius of curvature associated with the shape of
pound units are to be regarded separately as standard. The
the needle.
values stated in each system may not be exact equivalents;
3.2.2 needle test gripping location, n—area in front of the
therefore, each system shall be used independently of the other.
attachment zone or tangent portion of the needle where the
needle will be clamped/secured in the test fixture.
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This test method is under the jurisdiction of ASTM Committee F04 on Medical
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and Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.33 on Medical/Surgical Instruments. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved March 1, 2014. Published April 2014. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3014-14. the ASTM website.
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F3014 − 14
TABLE 2 Straight Surgical Needle Testing Ranges
3.2.2.1 Discussion—3.2.2 can be exempt for exceptionally
small needles. Approximate Percent
Overall Needle
Length of Testing
Length
(before Cutting, if Applicable)
4. Summary of Test Method
5 to 152 mm 30
4.1 Securely clamp the needle into the clamping fixture in a
153 mm and longer 30
uniform area in front of the attachment zone or tangent portion
of the needle, distal to the needle point. Thi
...