This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should...
This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1)2 of plantar flexion, as determined by non-clinical testing. Included within the...
These methods cover procedures for testing hydraulic spray nozzles used in agriculture. The methods herein cover the following performance parameters: nozzle flow rate, nozzle spray angle, liquid distribution, spray droplet size, and nozzle wearability. These methods are applicable to hydraulic...
This test method provides a protocol for capturing, concentrating, and testing the adenosine triphosphate (ATP) present in a fuel system sub-sample (that is, test specimen) associated with: Microorganisms and hydrophilic particles found in liquid fuels as described in Table X6.1, or Microorganisms...
This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the pre-dough or dough stage in accordance with the manufacturer's recommendations. Units of pre-measured powder and liquid are supplied in a form...
This test method describes a laboratory method for evaluating the potential for mobile bearing knee tibial baseplate/bearing disassociation under repeated forces. The test described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism.With modification, the...
This test method is designed to provide a standardized method to determine the dislocation resistance of mobile bearing knee designs with regard to femoral component disassociation and spin-out/spit-out of the mobile bearing insert. Although the methodology described does not replicate all...
This practice covers a laboratory-based in-vitro method for evaluating the mechanical performance of materials and devices being considered for replacement of the tibio-femoral joint in human knee joint replacement prostheses in mobile bearing knee systems. Mobile bearing knee systems permit...
This guidance document provides metallurgical characterization information that may be beneficial in the evaluation of absorbable metallic materials intended for medical implant applications. This guide is primarily intended for absorbable metallic materials that undergo further...
This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 23manganese-21chromi
This guide covers procedures for obtaining laboratory data concerning the short-term chronic effects of a test material on echinoderm embryos and the resulting larvae (sea urchins and sand dollars) during static 48- to 96-h exposures. These procedures have generally been used with U.S. East...
This guide describes procedures for obtaining laboratory data concerning the acute effects of a test material on embryos and the resulting larvae of four species of saltwater bivalve molluscs (Pacific oyster, Crassostrea gigas Thunberg; eastern oyster, Crassostrea virginica Gmelin; quahog or...
This specification is intended to cover all the widely used generic types of knee replacement prostheses used to provide functioning articulation. This includes total knee replacement (TKR) and unicondylar knee replacement (UKR) prostheses of both fixed and mobile bearing varieties, and for primary...
This standard guide provides options and a compendium of information for measuring the bearing surface and estimating the in-vivo wear of explanted Metal-on-Metal (MoM) and other "hard" (for example, ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads...
This guide covers procedures for obtaining laboratory data concerning the adverse effects of a test material (added to dilution water, but not to food) on Daphnia magna Straus, 1820, during continuous exposure throughout a life-cycle using the renewal or flow-through techniques. These...
This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and...
The purpose of this guide is to assist users and producers of non-culture microbiological tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test procedures such as the Heterotrophic (Standard) Plate...
This test method covers a procedure to simulate dynamic impingement between femoral and acetabular components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined in 8.2); and, if necessary, quantitative assessment of changes in modular component attachment...
This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. This specification addresses medical masks with ties (surgical masks) and ear loops (procedure...
This practice covers the standardization of permeate flow for ultrafiltration (UF) systems. This practice is applicable to natural waters including brackish waters, seawaters, and ultrapure waters including those used in power generation and microelectronics and pharmaceuticals production. It is...