ASTM F1635 - 16 - Standard Test Method for <i>in</i> <i>vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

ASTM F1635 - 16

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

Status : Current   Published : December 2016

Format
PDF

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HARDCOPY



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.




Standard NumberASTM F1635 - 16
TitleStandard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
StatusCurrent
Publication Date01 December 2016
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Biological test, Degradation, Degradation/deterioration, Fabrication, Hydrolytically degradable plastics, Hydrolytically degradable polymers, In vitro evaluation, Manufacturing process, Plastics, Polymer resins, Surgical implants
ICS11.040.40
PublisherASTM
FormatA4
DeliveryYes
Pages7
File Size103 KB
Price£40.00


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