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ISO 10282:2023 - Single-use sterile rubber surgical gloves — Specification
- This document specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. This...
ISO 23416:2023 - General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles
- This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to...
ISO 24329:2022 - Low-protein natural rubber latex concentrate — Specification
- This document provides specifications for natural rubber latex concentrate which has low protein content [low protein natural rubber (LPNR) latex], as follows:—    LPNR latex: field...
ISO/ASTM TR 52916:2022 - Additive manufacturing for medical — Data — Optimized medical image data
- This document includes the creation of optimized data for medical additive manufacturing (MAM). These data are generated from static modalities, such as magnetic resonance imaging (MRI),...
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...