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  • ASTM
    F2791-24 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions (Redline)
    Edition: 2024
    $103.58
    Unlimited Users per year

Description of ASTM-F2791 2024

ASTM F2791-24

Redline Standard: Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions




ASTM F2791

Scope

1.1 This guide describes some of the more common methods that are available for measuring the topographical features of a surface and provides an overview of the parameters that are used to quantify them. Being able to reliably derive a set of parameters that describe the texture of biomaterial surfaces is a key aspect in the manufacture of safe and effective implantable medical devices that have the potential to trigger an adverse biological reaction in situ.

1.2 This guide is not intended to apply to porous structures with average pore dimensions in excess of approximately 50 nm (0.05 μm).

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Keywords

biomaterial; characterization; optical instrument; non-porous; profile; roughness; stylus instrument; surface texture; waviness;


ICS Code

ICS Number Code 17.040.20 (Properties of surfaces)


DOI: 10.1520/F2791-24

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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