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2.1 This Standard establishes general requirements for human health and environmental criteria for industrial, institutional, and consumer cleaning and cleaning-related products such as but not limited to: a) Hard Surface Cleaners: 1) Bathroom cleaners (Non-Disinfecting); 2) Boat and bilge...
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...
1.1 These requirements apply to portable germicidal equipment intended to expose the air and surfaces within an unoccupied area with uncontained ultraviolet (UV) energy. These requirements address equipment intended to remain stationary while in operation, and intended for use by ordinary persons....
This specification covers polyetheretherketone
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 natural orifice...
4.1 Antimicrobial agents are routinely used for treating textile materials for the reduction of biodeterioration and bacterial odor generation. Furthermore, textiles are treated to prevent or limit microbial cross-contamination in healthcare settings. 4.2 Antimicrobial agents used in textiles will...
4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying...
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 materials or medical...
5.1 This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition...
4.1 A variety of products and materials are irradiated with X-radiation to modify their characteristics and improve the economic value or to reduce their microbial population for health-related purposes. Dosimetry requirements might vary depending on the type and end use of the product. Some...
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, and may...
4.1 Single-use systems (SUSs) used for biopharmaceutical manufacturing must maintain sterility and product quality of the fluid inside. Such articles or systems should therefore be validated as providing an effective barrier against microbial ingress. The microbial barrier properties of a SUS may...
4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying...
4.1 This practice summarizes a method that may be used to accelerate the oxidation of UHMWPE components using elevated temperature and elevated oxygen pressure. Under real-time conditions, such as shelf aging and implantation, oxidative changes to UHMWPE after sterilization using high-energy...
1.1 This specification covers the referee test methods for evaluating the performance characteristics of a single-use ureteral stent with retaining means at both ends, during short-term use for drainage of urine from the kidney to the bladder. These stents are typically available in diameters of 3...
1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs)); all dosage forms; over-the-counter...
This specification covers rubber-coated cloth hospital sheeting intended for use in the protection of mattresses on hospital beds. The base cloth should be hospital sheeting woven from cotton yarn, synthetic yarn, or a blend of both. The coating should be made from natural rubber, synthetic rubber,...
1.1 This specification establishes design, performance, documentation, and labeling requirements and provides test methods for protective clothing used in preventing exposure to liquid chemotherapy and other liquid hazardous drugs. 1.1.1 The principal requirement of this specification is permeation...
4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying...
This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast. This specification does not cover custom fabricated implantable...
