Credit card payment only is accepted for this order because it contains a mix of both publications and training products.
Invalid username/password. Please try again.
xyz
Standard Guide for Testing Absorbable Stents
:
Available format(s): Hardcopy, PDF
Superseded date: 04-01-2022
Language(s): English
Published date: 27-12-2013
Publisher: American Society for Testing and Materials
CONTAINED IN VOL. 13.02, 2015 Defines select physical and mechanical Characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following interventional revascularization procedures.
1.1This Guide covers select physical and mechanical characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following interventional revascularization procedures. This Guide covers devices that are fabricated from one or more degradable polymers and/or metals (from this point on referred to as “absorbable”). This Guide provides a framework for evaluating the change in select physical and mechanical characteristics of absorbable stents from manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards for stent evaluation.
1.2Recommendations specific to non-absorbable stents with absorbable coatings are not within scope.
1.3Recommendations specific to testing absorbable stent grafts are not provided here, however this standard has many elements applicable to testing absorbable stent grafts.
1.4Clinical need dictates that absorbable stents initially possess the same general dimensions and mechanical function as their non-absorbable counterparts. Thus, utilization of already established mechanical stent evaluation methods is possible when absorbable test specimens are previously conditioned under physiologically relevant temperature and humidity. As a result, this standard addresses absorbable-specific testing issues related to the mechanical and physical evaluation of these devices. This standard is limited to providing absorbable-specific testing recommendations for evaluations where an ASTM method for durable (i.e., non-absorbable) stents is already available. Specifically, this standard provides testing recommendations for adapting the elastic recoil (ASTM F2079), securement/dislodgement (ASTM F2394), and three-point bending (ASTM F2606) tests to fully absorbable devices. This guide generally describes specimen conditioning, as appropriate, for absorbable devices, which can range from none to extensive – depending on the measured attribute and relevant clinical exposure conditions, including time in the in-use environment. There are additional stent evaluation methods that are not addressed explicitly in this guide, e.g., chronic durability, that may require absorbable-specific provisions. The user should justify the appropriate testing for the specific polymer and device.
1.4.1While the primary purpose of this guide is to address absorbable stent-related issues specific to the tests described in Section 1.3, additional testing (e.g., radial strength) will likely also be needed. Thus, aspects of what is presented herein may be applicable to additional relevant device attributes, such as those described in ISO 25539-1 and/or 25539-2.
1.5This Guide may not be appropriate for all absorbable devices, for example those that possess limited hydrolytic or corrosion susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application.
1.6This Guide does not address the methods necessary to characterize the chemical degradation of the absorbable stent (e.g., changes in mass, molecular weight, or degradants). However, this type of characterization does represent an important component of the degradation profile and mechanism of the device. These characterizations are addressed in ASTM F1635.
1.7The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8This 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 and health practices and determine the applicability of regulatory limitations prior to use.
AUD CAD CHF CNY DKK EUR GBP HKD IDR INR JPY KRW MXN NOK NZD SEK SGD USD ZAR
Unfortunately, this product is not available for purchase in your region.
Features
Get in touch with us
Loading..
A free alerting service to track changes to standards.
Once you've completed your purchase you'll get a link to My Orders on: -the Confirmation page of check out -and by email You'll be able to access your Multi User Orders to add Users.
You have selected more than three (3) participants. Please contact our Customer Service team.
You have already added this product in the cart. If you would like to add additional copies of this product please adjust the Quantity in the cart. For more than 10 copies, please contact our Customer Support team on +353 (0)1 857 6730.
You have selected more than three (3) trainings. Please contact our Customer Service team.Please contact our Customer Service team on Email: sales@saiglobal.com Phone: 131 242 (Within Australia)
You have already added a product with different Currency. Please change the currency.
This product cannot be added to your cart right now. Please contact our Customer Service team on Email: info@standards.iePhone: +353(0)1 857 6730
You have already saved 6 Quotes. Please contact our Customer Service Team.