ASTM F1874-98

Standard Test Method for Bend Testing of Needles Used in Surgical Sutures

SCOPE
1.1 This test method describes the procedure for bend testing needles used for the placement of surgical sutures.
1.2 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.

General Information

• Status: Historical
• Publication Date: 09-Apr-1998
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

Relations

• Replaced By: ASTM F1874-98(2004) - Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
• Effective Date: 01-May-2004

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
Designation:F1874–98
Standard Test Method for
Bend Testing of Needles Used in Surgical Sutures
This standard is issued under the fixed designation F 1874; 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 5. Significance and Use
1.1 This test method describes the procedure for bend 5.1 This test method provides a means of assessing the yield
testing needles used for the placement of surgical sutures. moment and maximum moment of a surgical needle.
1.2 This standard does not purport to address all of the 5.2 The needle is bent against a platform or knife edge, and
safety concerns, if any, associated with its use. It is the it is bent at the approximate location where a pair of needle
responsibility of the user of this standard to establish appro- holders would grip it. This simulates the actual bending of a
priate safety and health practices and determine the applica- needle while in surgical use.
bility of regulatory limitations prior to use.
6. Apparatus
2. Referenced Documents
6.1 Clamping Fixture—Adevice to firmly clamp and rotate
2.1 ASTM Standards: the needle.
F 1840 Terminology for Surgical Suture Needles 6.2 Bending Platform— The surface on which the curved
needle will exert force during the test. The bending platform
3. Terminology
will have its top surface located along the horizontal axis of the
3.1 Definitions— Definitions of terms used in this test center of rotation of the clamping fixture.
method are in accordance with Terminology F 1840.F 1840
6.3 Knife Edge—The knife edge will be placed parallel to
3.2 Definitions of Terms Specific to This Standard: the centerline of rotation to provide a single point contact for
3.2.1 needle test gripping location, n— for test methods, the
reading the torque generated by the needle.
needlewillbeclampedtwo-thirdsofthedistancebackfromthe 6.4 Data Collection System—The data will be collected as a
point of the needle. Since the needle will deform during the
function of rotational angle.
bend test, the needle test gripping location only applies to an 6.5 Rotation Speed— The clamping fixture must be rotated
unbent needle. at a continuous and constant speed.This speed will be less than
3.2.2 test chord length, n—the straight line distance from
30°/s.
the center of rotation of the needle in the test fixture to the
7. Sampling
initial point of contact with the bending platform or knife edge.
7.1 Asample size of no less than five needles shall be used.
4. Summary of Test Method
8. Procedure (see Fig. 1)
4.1 Surgical needles are grasped approximately two-thirds
of the distance from the point of the needle, then bent against 8.1 Securely clamp the needle into the clamping fixture at a
a knife edge or platform. The force deflection data obtained position approximately two-thirds of the distance back from
from the test will be used to calculate the yield bend moment the tip of the needle.
and the maximum bend moment. 8.2 Rotate the clamping fixture forward until the needle
4.2 The decision to use a knife edge or a platform for the touches the bending platform or knife edge. Continue rotating
bendingsurfacewillbedeterminedbytheequipmentavailable. the clamping fixture through a sufficient angle to generate the
required data. While the needle is bending, collect the bending
force data as a function of the bend angle.
ThistestmethodisunderthejurisdictionofASTMCommitteeF-04onMedical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
9. Calculation (see Fig. 2)
F04.33 on Medical/Surgical Instruments.
9.1 Data w
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