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  • ASTM
    F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    Edition: 2016
    $78.62
    Unlimited Users per year

Description of ASTM-F1635 2016

ASTM F1635-16

Active Standard: Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants




ASTM F1635

Scope

1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.

1.2 The requirements of this test method apply to HDPs in various forms:

1.2.1 Virgin polymer resins, or

1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.

1.3 This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.

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

1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.


Keywords

absorbable; bioabsorbable; degradation; in vitro; hydrolytically degradable polymer; hydrolysis; PLA, poly(l-lactic acid); poly(d-lactide); poly(d,l-lactide); PGA, poly(glycolide); poly(caprolactone); poly(p-dioxanone); surgical implant;


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F1635-16

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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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