Standard Test Method for Bend Testing of Needles Used in Surgical Sutures (Withdrawn 2020)

SIGNIFICANCE AND USE
This test method provides a means of assessing the yield moment and maximum moment of a surgical needle.
The needle is bent against a platform or knife edge, and it is bent at the approximate location where a pair of needle holders would grip it. This simulates the actual bending of a needle while in surgical use.
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.
WITHDRAWN RATIONALE
This test method described the procedure for bend testing 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Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this test method was withdrawn in July 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the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Withdrawn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
31-May-2011
Withdrawal Date
07-Jul-2020
Current Stage
Ref Project

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ASTM F1874-98(2011) - Standard Test Method for Bend Testing of Needles Used in Surgical Sutures (Withdrawn 2020)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F1874 − 98 (Reapproved 2011)
Standard Test Method for
Bend Testing of Needles Used in Surgical Sutures
This standard is issued under the fixed designation F1874; 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.
1. Scope 4.2 The decision to use a knife edge or a platform for the
bendingsurfacewillbedeterminedbytheequipmentavailable.
1.1 This test method describes the procedure for bend
testing needles used for the placement of surgical sutures.
5. Significance and Use
1.2 This standard does not purport to address all of the
5.1 This test method provides a means of assessing the yield
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- moment and maximum moment of a surgical needle.
priate safety and health practices and determine the applica-
5.2 The needle is bent against a platform or knife edge, and
bility of regulatory limitations prior to use.
it is bent at the approximate location where a pair of needle
holders would grip it. This simulates the actual bending of a
2. Referenced Documents
needle while in surgical use.
2.1 ASTM Standards:
F1840 Terminology for Surgical Suture Needles
6. Apparatus
6.1 Clamping Fixture—A device to firmly clamp and rotate
3. Terminology
the needle.
3.1 Definitions—Definitions of terms used in this test
6.2 Bending Platform—The surface on which the curved
method are in accordance with Terminology F1840.
needle will exert force during the test. The bending platform
3.2 Definitions of Terms Specific to This Standard:
will have its top surface located along the horizontal axis of the
3.2.1 needle test gripping location, n—for test methods, the
center of rotation of the clamping fixture.
needlewillbeclampedtwo-thirdsofthedistancebackfromthe
point of the needle. Since the needle will deform during the
6.3 Knife Edge—The knife edge will be placed parallel to
bend test, the needle test gripping location only applies to an
the centerline of rotation to provide a single point contact for
unbent needle.
reading the torque generated by the needle.
3.2.2 test chord length, n—thestraightlinedistancefromthe
6.4 Data Collection System—The data will be collected as a
center of rotation of the needle in the test fixture to the initial
function of rotational angle.
point of contact with the bending platform or knife edge.
6.5 Rotation Speed—The clamping fixture must be rotated
at a continuous and constant speed.This speed will be less than
4. Summary of Test Method
30°/s.
4.1 Surgical needles are grasped approximately two-thirds
of the distance from the point of the needle, then bent against
7. Sampling
a knife edge or platform. The force deflection data obtained
from the test will be used to calculate the yield bend moment
7.1 Asample size of no less than five needles shall be used.
and the maximum bend moment.
8. Procedure (see Fig. 1)
8.1 Securely clamp the needle into the clamping fixture at a
This test method is under the jurisdiction ofASTM Committee F04 on Medical
position approximately two-thirds of the distance back from
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.33 on Medical/Surgical Instruments the tip of the needle.
Current edition approved June 1, 2011. Published July 2011. Originally approved
8.2 Rotate the clamping fixture forward until the needle
in 1998. Last previous edition approved in 2004 as F1874 – 98(2004). DOI:
10.1520/F1874-98R11.
touches the bending platform or knife edge. Continue rotating
For referenced ASTM standards, visit the ASTM website, www.as
...

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