ASTM International news
A new ASTM standard provides an easy-to-perform test method for growing different strains of Clostridium difficile spores, which are used by microbiologists to evaluate antimicrobial drugs.
Spore crops grown using the test method (soon to be published as E3011, Test Method for in vitro Production of Clostridium Difficile Spores) will be used in laboratories to test the efficacy of drugs that fight C. difficile, a source of infectious intestinal diseases such as colitis.
Subcom
On July 8 of this year, in Washington, D.C., the United States and the European Union launched negotiations on a proposed free trade agreement called the Transatlantic Trade and Investment Partnership, or TTIP. While the two parties have negotiated free trade agreements with other countries, they have not, until now, attempted one of this magnitude with one another.1 In its Technical Barriers to Trade section, the agreement is slated to cover, among other things, cars, machinery and electroni
The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.
1. Scope
1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example drug-devices, biologic
Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.
This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in
The shear and bending fatigue tests are used to determine the effect of variations in material, geometry, surface condition, stress, and so forth, on the fatigue resistance of coated metallic materials subjected to direct stress for up to 107 cycles. These tests may be used as a relative guide to the selection of coated materials for service under condition of repeated stress.
In order that such basic fatigue data be comparable, reproducible, and can be correlated among lab
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling constructions shall be 7×7 and 7×19 cable. Mechanical requirements include ultimate ten
This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. Physical and mechanical properties of medical grade polyoxymethylene such as specific gravity, water absorption, equilibrium, tensile y
This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties.
Silicone manufacturers supplying material to the medical device industry should readily provide information regar
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications.
Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or through the US FDA master file program.
1. Scope
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the chemical composition requirements specified. Product analysis tolerances do not broaden the