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F2559/F2559M Standard Guide for Writing a Specification for Sterilizable Peel Pouches has been revised to F2559/F2559M-21
18/11/2021 - Significance and Use 5.1 Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different...
F3036 Standard Guide for Testing Absorbable Stents has been revised to F3036-21
18/11/2021 - Significance and Use 4.1 Absorbable cardiovascular stents provide temporary support to the vasculature and are intended to degrade and absorb over time after being implanted...
F3046 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320) has been revised to F3046-21
- 1. Scope 1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-2.5vanadium alloy (R56320) to be used in...
F3504 Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method is a new standard now available. F3504-21
- Significance and Use 5.1 In-vitro cell proliferation assays are used to screen the capability of cells to proliferate and self-renew within scaffolds for regenerative medicine...
ISO 25518:2021 - Single-use rubber gloves for general applications — Specification
01/10/2021 - This document specifies the physical requirements and sampling and testing methods for single-use rubber gloves, made from natural rubber latex, synthetic rubber latex or rubber solution,...
F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants has been revised to F1798-21
- Significance and Use 5.1 Spinal implants are generally composed of several components that, when connected together, form a spinal implant construct. Spinal implant constructs...
F1108 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) has been revised to F1108-21
- Abstract This specification covers the chemical, mechanical, and metallurgical requirements for cast titanium-6aluminum-4vanadium alloy (UNS R56406). Castings conforming to...
F1586 Standard Specification for Wrought Nitrogen Strengthened 21Chromiumâ??10Nickelâ??3Manganeseâ??2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675) has been revised to F1586-21
- Abstract This specification covers the chemical composition, mechanical, and metallurgical requirements for wrought nitrogen strengthened...
F2211 Standard Classification for Tissue-Engineered Medical Products (TEMPs) has been reapproved, available as F2211-13(2021)
- Significance and Use 4.1 This classification outlines aspects of TEMPs which includes their individual components. 4.2 The categories outlined in this classification...
F3505 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance is a new standard now available. F3505-21
- Significance and Use 5.1 Upon deployment of a stent or endovascular prosthesis, the device is intended to maintain the patency of the vascular vessel. In order to maintain...
F1781 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants has been revised to F1781-21
- Abstract This specification covers the biocompatibility and other performance requirements, and associated test methods for elastomeric flexible hinge finger total joint...
F1813 Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120) has been revised to F1813-21
- Abstract This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12 molybdenum- 6 zirconium-2 iron alloy for surgical...
F2514 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading has been revised to F2514-21
- Significance and Use 4.1 Finite element analysis is a valuable tool for evaluating the performance of metallic stents and in estimating quantities such as stress, strain, and...
F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) has been editorially changed, available as F136-13(2021)e1
- Abstract This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial)...
F621 Standard Specification for Stainless Steel Forgings for Surgical Implants has been editorially changed, available as F621-12(2021)e1
- Abstract This specification covers the requirements for stainless steel forgings for surgical implants. Materials for forgings shall be bars or wire and shall be forged by...
F746 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials has been reapproved, available as F746-04(2021)
- Significance and Use 4.1 This test method is designed solely for determining comparative laboratory indices of performance. The results may be used for ranking alloys in order...
F2606 Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems has been reapproved, available as F2606-08(2021)
- Significance and Use 3.1 This guide can be used to obtain force versus deflection or midspan bending moment versus midspan curvature curves for stents and stent systems...
F3067 Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents has been reapproved, available as F3067-14(2021)
- Significance and Use 4.1 Upon deployment, at the site of the vascular stenosis, the stent establishes the patency of the lumen until vascular remodeling occurs. The radial load...
F3515 Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications is a new standard now available. F3515-21
- Significance and Use 5.1 The purpose of this guide is to provide guidance on characterization of the properties of porcine fibrinogen as a starting material for surgical...
D8389 Standard Performance Specification for Urinary Intermittent Catheters is a new standard now available. D8389-21
- 1. Scope 1.1 This performance specification establishes performance requirements for the short-term utilization of a single-use, non-balloon- urinary catheter, French...