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.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

1. 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.

Keywords

cardiovascular surgical devices; carotid occlusion; clamps; disclosure; occlusions; resistance-slip; screw-type clamps; Cardiovascular surgical devices; Carotid occlusion; Clamps; Disclosure; Occlusions; Screw-type clamps; Slip resistance;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Citing ASTM Standards

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