ASTM F982-86(2002)

Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion

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.

General Information

• Status: Historical
• Publication Date: 26-Mar-1986
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaces: ASTM F982-86(1998) - Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion
• Effective Date: 27-Mar-1986
• Replaced By: ASTM F982-86(2008) - Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
• Effective Date: 01-Feb-2008

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 982 – 86 (Reapproved 2002)
Standard Specification for
Disclosure of Characteristics of Surgically Implanted
1
Clamps for Carotid Occlusion
This standard is issued under the fixed designation F 982; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 Thisspecificationcoversrequirementsforthedisclosure
of specific characteristics of screw-type adjustable clamps that
are designed for the gradual permanent occlusion of carotid
arteries.Thesedevicesconsistofanimplantableportionandan
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 limita-
tions prior to use.
2. Referenced Documents
2.1 The designations and titles of the applicable documents
for this specification are listed in Annex A1 in the following
groups:
2.1.1 Materials,
2.1.2 Finishing,
2.1.3 Biocompatibility,
2.1.4 Handling, and
2.1.5 Analysis.
3. Terminology FIG. 1 Screw-Type Adjustable Clamp Components
3.1 Descriptions of Terms Specific to This Standard (see
Fig. 1): 3.1.6 hinge—means of attaching the access plate to the
3.1.1 access plate—portion of the device that closes the frame.
frame. 3.1.7 pressure plate—movable compressing plate.
3.1.2 cap—covering device to seal the lumen of the stem 3.1.8 pressure plate screw—threaded shaft that advances
when the screwdriver is not in place. the pressure plate.
3.1.3 collar—threaded portion of the frame that acts as a 3.1.9 screwdriver—device used to provide torque to the
guide and counter torque surface for the pressure plate screw. pressureplatescrew.Thescrewdrivershouldhavepermanently
3.1.4 frame—encircling portion of the device, usually marked scale indicating advance ratio by millimetres.
U-shaped. 3.1.10 set screw—screw that secures the access plate to the
3.1.5 guide—cylinder within the stem to provide counter frame.
torque and guidance for the screwdriver. 3.1.11 stem—cylinder that is used to hold the frame and to
provide counter torque for the screwdriver.
1
This specification is under the jurisdiction of ASTM Committee F04 on
4. General Requirements
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1 This section contains requirements for disclosure of
Subcommittee F04.31 on Neurosurgical Standards.
Current edition approved March 27, 1986. Published May 1986. information on screw-type adjustable clamps.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F 982 – 86 (2002)
4.2 Performance Disclosure: physiologic systolic-diastolic pattern (150/80 at 80 cpm).
4.2.1 Materials: During the experiment, keep the artery in a normal saline bath
4.2.1.1 The manufacturer shall disclose the generic names and connect it to the pulse duplicator system. Close the clamp
of the materials used in the manufacture of the clamp. to a gap of 2 mm.Turn on the pulse duplicator and measure the
Whenever available, ASTM material specification nomencla- position of the pressure plate relative to the basis of the frame
ture shall be used (Annex A1). If multiple components are every 24 h for 72 h to determine if there has been any retreat
used, the names of each component shall be disclosed. of the pressure plate. Perform a second test keeping the pulse
4.2.1.2 The metals and alloys or other materials used in duplicator functioning at the same setting but with the clamp
clamps that conform to this specification should be fabricated closed down to occlude the artery using the torque determined
of approved materials in accordance with the ASTM specifi- safe as detailed in 5.2. Again, measure the position of the
cations listed in A1.2.1. pressure plate every 24 h for 72 h. A backoff of 0.2 mm (90°
4.2.2 Finishing—Surface cleanliness and characteristics turn) will be the maximum permitted. Measurement must be
shouldmeettherequirementsoftheASTMspecificationslisted accurate to 60.35 mm.
in A1.2.2. There should be no debris visible at 203 and no
imperfections visible to the naked eye. 6. Labeling Requirements
4.2.3 Biocompatibility—Clamps should be biocompatible
6.1 All labeling must be consistent with applicable Federal
with the tissue in which they are intended to be implanted.
Regulati
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