ASTM F982-86(2008)
(Specification)Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
ABSTRACT
This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver. The manufacturer shall disclose the generic names of the materials used in the manufacture of the clamp, the advance ratio, pressure plate induced laceration of vessel, and slip resistance of the clamp.
SCOPE
1.1 This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver (see Fig. 1).
1.2 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: 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WITHDRAWN RATIONALE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 specification covered requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in July 2017 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the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.
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F982 −86 (Reapproved 2008)
Standard Specification for
Disclosure of Characteristics of Surgically Implanted
Clamps for Carotid Occlusion
ThisstandardisissuedunderthefixeddesignationF982;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.5 guide—cylinder within the stem to provide counter
torque and guidance for the screwdriver.
1.1 Thisspecificationcoversrequirementsforthedisclosure
3.1.6 hinge—means of attaching the access plate to the
of specific characteristics of screw-type adjustable clamps that
frame.
are designed for the gradual permanent occlusion of carotid
arteries.Thesedevicesconsistofanimplantableportionandan
3.1.7 pressure plate—movable compressing plate.
externally projecting removable screwdriver (see Fig. 1).
3.1.8 pressure plate screw—threadedshaftthatadvancesthe
1.2 The following precautionary caveat pertains only to the
pressure plate.
test method portion, Section 5, of this specification: This
3.1.9 screwdriver—device used to provide torque to the
standard does not purport to address all of the safety concerns,
pressureplatescrew.Thescrewdrivershouldhavepermanently
if any, associated with its use. It is the responsibility of the user
marked scale indicating advance ratio by millimetres.
of this standard to establish appropriate safety and health
3.1.10 set screw—screw that secures the access plate to the
practices and determine the applicability of regulatory limita-
frame.
tions prior to use.
3.1.11 stem—cylinder that is used to hold the frame and to
2. Referenced Documents provide counter torque for the screwdriver.
2.1 The designations and titles of the applicable documents
4. General Requirements
for this specification are listed in Annex A1 in the following
4.1 This section contains requirements for disclosure of
groups:
information on screw-type adjustable clamps.
2.1.1 Materials,
2.1.2 Finishing,
4.2 Performance Disclosure:
2.1.3 Biocompatibility, 4.2.1 Materials:
2.1.4 Handling, and
4.2.1.1 The manufacturer shall disclose the generic names
2.1.5 Analysis. of the materials used in the manufacture of the clamp.
Whenever available, ASTM material specification nomencla-
3. Terminology
ture shall be used (Annex A1). If multiple components are
used, the names of each component shall be disclosed.
3.1 Descriptions of Terms Specific to This Standard (see ):
4.2.1.2 The metals and alloys or other materials used in
3.1.1 access plate—portion of the device that closes the
clamps that conform to this specification should be fabricated
frame.
of approved materials in accordance with the ASTM specifi-
3.1.2 cap—covering device to seal the lumen of the stem
cations listed in A1.2.1.
when the screwdriver is not in place.
4.2.2 Finishing—Surface cleanliness and characteristics
3.1.3 collar—threaded portion of the frame that acts as a
shouldmeettherequirementsoftheASTMspecificationslisted
guide and counter torque surface for the pressure plate screw.
in A1.2.2. There should be no debris visible at 20× and no
imperfections visible to the naked eye.
3.1.4 frame—encircling portion of the device, usually
U-shaped. 4.2.3 Biocompatibility—Clamps should be biocompatible
with the tissue in which they are intended to be implanted.
Metal components shall meet ASTM biologic compatibility
requirements or equivalents listed in A1.2.3. Nonporous poly-
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
meric materials should conform to theASTM requirements or
Subcommittee F04.31 on Neurosurgical Standards.
equivalents listed in the Annex.
Current edition approved Feb. 1, 2008. Published March 2008. Originally
4.2.4 Handling—Handling procedures should be similar to
approved in 1986. Last previous edition approved in 2002 as F982–86 (2002).
DOI: 10.1520/F0982-86R08. those suggested by several ASTM standards listed in A1.2.4.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F982 − 86 (2008)
distensibility and a pulse duplicator system. Set the pulse
duplicator to create a pulsatile cycle of pressure similar to the
physiologic systolic-diastolic pattern (150/80 at 80 cpm).
During the experiment, keep the artery in a normal saline bath
and connect it to the pulse duplicator system. Close the clamp
toagapof2mm.Turnonthepulseduplicatorandmeasurethe
position of the pressure plate relative to the basis of the frame
every 24 h for 72 h to determine if there has been any retreat
of the pressure plate. Perform a second test keeping the pulse
duplicator functioning at the same setting but with the clamp
closed down to occlude the artery using the torque determined
safe as detailed in 5.2. Again, measure the position of the
pressure plate every 24 h for 72 h. A backoff of 0.2 mm (90°
turn) will be the maximum permitted. Measurement must be
accurate to 60.35 mm.
6. Labeling Requirements
6.1 All labeling must be consistent with applicable Federal
Regulations. In addition, the labeling for carotid occlusive
clamps within the scope of this specification should comply
with the following requirements:
6.1.1 Package Label—The following information shall be
available with the unit package:
6.1.1.1 Manufacturer’s name,
FIG. 1 Screw-Type Adjustable Clamp Components
6.1.1.2 Trade name,
6.1.1.3 Catalog number,
6.1.1.4 Manufacturer’s identification or lot number,
4.2.5 Analysis—Analysis of clips removed for any reason
6.1.1.5 Material(s),
should resemble that specified for removal of orthopedic
6.1.1.6 Magnetic properties,
implants (see A1.2.5).
6.1.1.7 Advance ratio,
4.2.6 Reporting of Failures—Allfailuresshouldbereported
6.1.1.8 Torque which causes vessel laceration, and
both to the manufacturer and to the Food and Drug Adminis-
6.1.1.9 Slip resistance.
tration (FDA).
6.1.2 Product Insert—The product insert should include the
4.2.7 Advance Ratio—The manufacturer shall disclose the
following information:
distance (millimetres) advanced by the pressure plate for each
6.1.2.1 Manufacturer’s name,
full revolution of the screwdriver (see also 5.1).
4.2.8 Pressure Plate Induced Laceration of Vessel—The 6.1.2.2 Trade name,
manufacturer shall disclose the torque at which the pressure 6.1.2.3 Catalog number,
plate will cause vessel laceration (see also 5.2).
6.1.2.4 Manufacturer’s identification or lot number,
4.2.9 Slip Resistance of the Clamp—The manufacturer shall 6.1.2.5 Size,
disclose whether the set screw will unwind and the pressure
6.1.2.6 Length of compression plate,
plate will retreat in the face of pulsatile pressure of 150/80 at
6.1.2.7 Width of compression plate,
80 cpm applied to the pressure plate when it is 2 mm from
6.1.2.8 Compression surface,
closure and when it is at the closed position (see also 5.3).
6.1.2.9 Advance ratio,
6.1.2.10 Internal dimensions of clamp when fully opened,
5. Test Methods
6.1.2.11 Material(s),
5.1 Advance Ratio—This measurement must be accurate t
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