ASTM International - ASTM F3510-21
Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
|Publication Date:||1 April 2021|
significance And Use:
5.1 The test methods contained herein guide characterization of the structural, physical, chemical, mechanical, and biological properties of a fiber-based construct. Such properties may be... View More
5.1 The test methods contained herein guide characterization of the structural, physical, chemical, mechanical, and biological properties of a fiber-based construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention; activity and organization; tensile strength; the delivery of bioactive agents; or the biocompatibility and bioactivity of the construct.
5.2 Tests described herein may be used for quality control during manufacturing or to assess how the product may perform its intended clinical function.
5.3 Plans for product development, product characterization, and the regulatory pathway should be discussed with the appropriate regulatory body.View Less
1.1 This guide is a resource for the characterization of fiber-based constructs intended for use in a tissue-engineered medical product (TEMP). There are existing standards that broadly cover scaffolds in a more generalized fashion (Guides F2150, F2450, F2900, F2902, ISO 21560). This guide focuses specifically on fiber-based constructs.
1.2 Fiber-based constructs may be fabricated by many different methods including, but not limited to the following: electrospinning, forcespinning, meltspinning, pneumatospinning, blowspinning, melt-electrowriting,
1.3 This guide will focus on constructs made of fibers wherein the average fiber diameter is within the range of approximately 100 nm to 100 µm.
1.4 For the purposes of this standard, a "fiber-based construct" is defined as a construct composed of slender, elongated filaments.
1.5 Units-The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
1.6 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.
1.7 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.