ASTM F1635-2016 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants《外科植入物用水降解聚酯和制作形式的体外降解试验.pdf
《ASTM F1635-2016 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants《外科植入物用水降解聚酯和制作形式的体外降解试验.pdf》由会员分享,可在线阅读,更多相关《ASTM F1635-2016 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants《外科植入物用水降解聚酯和制作形式的体外降解试验.pdf(7页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F1635 16Standard Test Method forin vitro Degradation Testing of Hydrolytically DegradablePolymer Resins and Fabricated Forms for SurgicalImplants1This standard is issued under the fixed designation F1635; the number immediately following the designation indicates the year oforiginal ado
2、ption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers in vitro degradation of hydro-lytically degrada
3、ble polymers (HDP) intended for use insurgical implants.1.2 The requirements of this test method apply to HDPs invarious forms:1.2.1 Virgin polymer resins, or1.2.2 Any form fabricated from virgin polymer such as asemi-finished component of a finished product, a finishedproduct, which may include pac
4、kaged and sterilized implants,or a specially fabricated test specimen.1.3 This test method provides guidance for mechanicalloading or fluid flow, or both, when relevant to the device beingevaluated. The specifics of loading type, magnitude, andfrequency for a given application are beyond the scope o
5、f thistest method.1.4 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard
6、 to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D638 Test Method for Tensile Properties of PlasticsD671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force
7、 (Withdrawn 2002)3D695 Test Method for Compressive Properties of RigidPlasticsD747 Test Method for Apparent Bending Modulus of Plas-tics by Means of a Cantilever BeamD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD882 Test Method
8、for Tensile Properties of Thin PlasticSheetingD1708 Test Method for Tensile Properties of Plastics by Useof Microtensile SpecimensD1822 Test Method for Tensile-Impact Energy to BreakPlastics and Electrical Insulating MaterialsD2857 Practice for Dilute Solution Viscosity of PolymersF748 Practice for
9、Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standards:4ISO 318 Physical Chemistry and Molecular Physics - Part8: Quantities and UnitsISO 109931 Biological Evaluation of Medical DevicesPart 1 Evaluation and TestingISO 109939 Biological Evaluation of Medical DevicesPart 9
10、 Framework for Identification and Quantification ofPotential Degradation ProductsISO 13781 Poly(L-lactide) resins and fabricated forms forsurgical implants In vitro degradation testing2.3 NIST Standard:5NIST Special Publication SP811 Guide for the Use of theInternational System of Units (SI)3. Termi
11、nology3.1 Definitions:1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Dec. 1, 2016. Published January 2017. Originallyapproved in 19
12、95. Last previous edition approved in 2011 as F1635 11. DOI:10.1520/F1635-16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page ont
13、he ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from National Institute of Standards and Technology (NIST), 10
14、0Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, at http:/physics.nist.gov/cuu/Units/bibliography.html.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally rec
15、ognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.1.1 absorbable, adjin the bodyan initially distinctforeign m
16、aterial or substance that either directly or throughintended degradation can pass through or be assimilated bycells and/or tissue.NOTE 1See Appendix X2 for a discussion regarding the usage ofabsorbable and other related terms.3.1.2 hydrolytically degradable polymer (HDP)any poly-meric material in wh
17、ich the primary mechanism of chemicaldegradation in the body is by hydrolysis (water reacting withthe polymer resulting in cleavage of the chain).3.1.3 resinany polymer that is a basic material for plas-tics.64. Summary of Test Method4.1 Samples of polymer resins, semi-finished components,finished s
18、urgical implants, or specially designed test specimensfabricated from those resins are placed in buffered salinesolution at physiologic temperatures. Samples are periodicallyremoved and tested for various material or mechanical prop-erties at specified intervals. The required test intervals varygrea
19、tly depending on the specific polymeric composition. Forexample, poly(l-lactide) and poly(e-caprolactone) degrade veryslowly and can require two or more years for completedegradation. Polymers based substantially on glycolide cancompletely degrade in two to three months depending on theexact composi
20、tion and on the size of the specimen. Degrada-tion time is also strongly affected by specimen size, polymermolar mass, and crystallinity.NOTE 2The term molecular weight (abbreviated MW) is obsolete andshould be replaced by the SI (Systme Internationale) equivalent of eitherrelative molecular mass (M
21、r), which reflects the dimensionless ratio of themass of a single molecule to an atomic mass unit see ISO 318, or molarmass (M), which refers to the mass of a mole of a substance and istypically expressed as grams/mole. For polymers and othermacromolecules, use of the symbols Mw, Mn, and Mzcontinue,
22、 referringto mass-average molar mass, number-average molar mass, and z-averagemolar mass, respectively. For more information regarding proper utiliza-tion of SI units, see NIST Special Publication SP811.5. Significance and Use5.1 This test method is intended to help assess the degrada-tion rates (th
23、at is, the mass loss rate) and changes in material orstructural properties, or both, of HDP materials used in surgicalimplants. Polymers that are known to degrade primarily byhydrolysis include but are not limited to homopolymers andcopolymers of l-lactide, d-lactide, d,l-lactide glycolide,caprolact
24、one, and p-dioxanone.75.2 This test method may not be appropriate for all types ofimplant applications or for all known absorbable polymers.The user is cautioned to consider the appropriateness of the testmethod in view of the materials being tested and their potentialapplication (see X1.1.1).5.3 Si
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