ASTM F619-2003 Standard Practice for Extraction of Medical Plastics《医学塑料制品萃取的标准实施规范》.pdf
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1、Designation: F 619 03Standard Practice forExtraction of Medical Plastics1This standard is issued under the fixed designation F 619; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses
2、indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers methods of extraction of medicalplastics and may be applicable to other materials. This practiceidentifies a method for obtaining “extr
3、act liquid” for use indetermining the biological response in preclinical testing.Further testing of the “extract liquid” is specified in otherASTM standards. The extract may undergo chemical analysisas part of the preclinical evaluation of the biological response,and the material after extraction ma
4、y also be examined.1.2 This practice may be used for, but is not limited to thefollowing areas: partial evaluation of raw materials, auditingmaterials within the manufacturing process, and testing finalproducts. This practice may also be used as a referee methodfor the measurement of extractables in
5、 plastics used in medicaldevices.1.3 The values stated in SI units are to be regarded as thestandard.1.4 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 to establish appro-priate safety and hea
6、lth practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 543 Practices for Evaluating the Resistance of Plastics toChemical ReagentsD 570 Test Method for Water Absorption of PlasticsD 1193 Specification for Reagent WaterD 1239
7、 Test Method for Resistance of Plastic Films toExtraction by ChemicalsD 1898 Practice for Sampling of Plastics3F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 Other Documents:USP NF 24 or current edition43. Terminology Definitions3.1 extraction vehiclea liq
8、uid specified for use in testingthe plastic. Specific extraction vehicles are to be designated bythe ASTM standard that references this practice (see Section 7for a list of standard extraction vehicles).3.2 extract liquidthat liquid which, after extraction of thespecimen, is used in tests.3.3 specim
9、en portionthe unit or units of plastic placedinto the extraction vehicle.3.4 blankthe extraction vehicle not containing the speci-men under test which is used for comparison with the extractliquid.4. Summary of Practice4.1 Standard-size specimens of the plastic, which mayclosely simulate the intende
10、d device depending upon the use,are immersed in defined volumes of selected liquids (extractionvehicles) for the time and temperature specified.4.2 A choice is made, based on the end use, of the extractionvehicles (see Section 7) and one of the combinations of timeand temperature for the test (see S
11、ection 12).4.3 The resultant test liquids (extract liquids) are kept inglass containers until used for testing. The test liquids shall bestored tightly stoppered at normal room temperature. Testliquids for biological testing are kept in sterile glass containers.Consideration should be given as to wh
12、ether the extractionshould be done under aseptic conditions. The test liquids forbiological testing should be used within 24 h.5. Significance and Use5.1 These extraction procedures are the initial part ofseveral test procedures used in the biocompatibility screeningof plastics used in medical devic
13、es.1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Nov. 1, 2003. Published December 2003. Originallyapproved in 1979. Last prev
14、ious edition approved in 2002 as F 619 02.2For 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 onthe ASTM website.3Withdrawn.4Availab
15、le from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.2 The limitations of the results obtained from this practiceshould be recognized. The choice of extraction v
16、ehicle, dura-tion of immersion, and temperature of the test is necessarilyarbitrary. The specification of these conditions provides a basisfor standardization and serves as a guide to investigatorswishing to compare the relative resistance of various plastics toextraction vehicles.5.3 Correlation of
17、 test results with the actual performance orserviceability of materials is necessarily dependent upon thesimilarity between the testing and end-use conditions (see12.1.2 and Note 4).5.4 Caution should be exercised in the understanding andintent of this practice as follows:5.4.1 No allowance or disti
18、nction is made for variables suchas end-use application and duration of use. Decisions onselection of tests to be done should be made based on PracticeF 748.5.4.2 This practice was originally designed for use withnonporous, solid materials. Its application for other materials,such as those that are
19、porous, or absorptive, or resorptive,should be considered with caution. Consideration should begiven to altering the specified material to liquid ratio to allowadditional liquid to fully hydrate the material and additionalliquid or other methods to fully submerge the test article.Additional procedur
20、es that fully remove the extract liquid fromthe test article, such as pressure or physically squeezing thematerial, should also be considered as appropriate. Although nodefinitions are given in this practice for the following terms,such items as extraction vehicle surface tension at the specifiedext
21、raction condition and plastic specimen physical structureshould be taken into account.5.5 Test Methods D 543, D 570, and D 1239 may be usefulin providing supplemental information.6. Apparatus6.1 Autoclave, capable of maintaining a temperature of 1216 2.0C (249.8 6 3.8F) for at least 1 h and equipped
22、 with adisplay of temperature and pressure. A slow exhaust cycle isnecessary. A rack to hold the extraction containers above thewater level is also necessary. Loss of fluid volume should berecorded.6.1.1 Sealed, unvented extraction vessels should not beremoved until internal temperature and pressure
23、 have reachedambient conditions and the door can be opened. It is recom-mended that the extraction vessels be left undisturbed until anyrisk of boil over has passed. When the extraction vessels arecool to the touch, the lids should be sealed.6.2 Heating Equipment:6.2.1 Ovens or incubators that will
24、maintain temperatures of37, 50, 70 6 2C (98, 122, 158 6 3F).6.2.2 Water baths capable of maintaining temperatures de-scribed in 6.2.1. Those with the ability to agitate the extractionvessels are preferred.6.3 Extraction ContainersSuitable containers that protectthe extract liquid from the biological
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