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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. Breast prosthesis are classified into three types: type I breast prosthesis, n - implantable breast prosthesis containing a single lumen containing a fixed amount of silicone gel, Type II breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other, and type III breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other. Elongation, breaking strength, tensile set, critical fused or adhered joints, shell rupture, and shell leakage shall be tested to meet the requirements prescribed. Gel cohesion, gel bleeding, and gel penetration shall be tested to meet the requirements prescribed.
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.
1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 Limitations—This specification does not cover custom fabricated implantable breast prostheses.
1.3 Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F 2051.
1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
1.5 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D1349 Practice for Rubber--Standard Temperatures for Testing
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I--Formulations and Uncured Materials
F2042 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II--Crosslinking and Fabrication
F2051 Specification for Implantable Saline Filled Breast Prosthesis
Other DocumentsISO/AAMI/ANSI10993-1 Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)