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4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and...
5.1 This guide describes the use of test methods in Guide F3276 to assess the compatibility of a brush part with the material substrates used in the construction of medical devices. 5.2 By providing objective, repeatable methods for evaluating performance under test conditions, this...
1.1 This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment. Note 1: "Medical devices and other items" will be referred to as "items" for the remainder of this practice. 1.2 The practice specifies the...
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...
1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (ß-TCP) raw materials intended for use in medical device applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this...
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. This method allows for comparison with or without the use of a body mimic. Comparisons without...
5.1 This practice is a guideline for a screening test of candidate materials or assessment of local tissue response to absorbable medical devices which are expected to undergo complete absorption within three years. 5.2 This practice is similar to those for studies on candidate...
This specification covers polyetheretherketone
1.1 These test methods cover the establishment of performance requirements for the utilization of a single-use, enteral feeding device with a retention balloon, used by medical professionals for providing a means of nutrition and/or administration of medication to patients by means of...
5.1 This standard guide is to be used to help assess the biocompatibility of materials used in medical devices (for example, externally communicating, implants, and other body contact medical devices). It is designed to test the effect of particles and other wear debris...
1.1 This guide covers general guidelines for the in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof,...
This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing...
5.1 This guide describes an approach to validate a cleaning system for a medical device. It is based on the manufacturer's accurate and comprehensive understanding of their internal manufacturing and cleaning processes. 5.2 This guide is not intended to provide a detailed plan or road...
4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants,...
5.1 This guide describes the use of test methods in Guide F3276 to assess the compatibility of a brush part with the material substrates used in the construction of medical devices. 5.2 By providing objective, repeatable methods for evaluating performance under test conditions, this...
4.1 The use of in vivo implantation techniques for characterizing the biocompatibility of implantable materials to be utilized in various medical applications enables the assessment of such materials not achieved by other procedures. Physical characteristics (that is, form, density,...
1.1 This specification covers thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts. 1.2 The epoxy encapsulants covered by this specification are intended to provide a tissue-compatible protective covering for implantable medical...
1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms that are generally understood and in common usage or adequately defined in other readily available...
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues. 1.2 This practice...
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues. 1.2 This practice...
