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This specification covers the requirements for wrought seamless or welded and drawn 18chromium-14nickel-
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2
This specification covers reusable Sahli hemoglobin pipets. The pipets shall be made of common spirit bore white back tubing. Pipet design shall be straight and of one-piece construction. Pipet delivery tips shall be made with a gradual or concave taper. Pipet dimensions shall be within...
5.1 In the battle to reduce medical device and implant-related infections, prevention of bacterial colonization of surfaces is a logical strategy. Bacterial colonization of a surface is a precursor to biofilm formation. Biofilm is the etiological agent of many implant and device-related infections...
1.1 This specification covers the requirements for five compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specification F138, F1314, F1586, F2229, or F2581. This specification addresses...
This specification covers the requirements for five compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specification F138, F1314, F1586, F2229, or F2581. This specification addresses those...
This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen...
This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen...
This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers. This document is applicable to colourless or amber glass containers made...
1.1 This specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial applications. 1.2 In general, needle tubing describes small-diameter tubing with outside diameters (ODs) in the range of 0.008 to 0.203 in. (0.2 to 5.2 mm) with nominal...
This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only. In addition, the pulse rate set on the NIBP simulator is tested. This...
This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only. In addition, the pulse rate set on the NIBP simulator is tested. This...
4.1 Conventional stainless-steel process equipment for biopharmaceutical manufacturing require cleaning and sterilization prior to implementation. Single-use systems (SUS), stand-alone equipment typically composed of plastic components and assemblies, are usually assembled in cleanrooms and are...
This specification covers the requirements for glass reusable blood diluting pipets that are used for performing red and white cell corpuscle determinations. The pipets shall be made of common spirit bore white back tubing or clear glass with a white stripe applied to the outer surface of...
This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers. This document is applicable to colourless or amber glass containers made...
WARNING - Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document. This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis,...
This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are...
