A number in parentheses indicates the year of last reapproval. It identifies one technique to quantify extract-able residue on metallic medical components. In addition, it isrecognized that this test method may not be the only method todetermine and quantify extractables. This test method is also not intended to extract residue for usein biocompatibility testing.
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A number in parentheses indicates the year of last reapproval. It identifies one technique to quantify extract-able residue on metallic medical components. In addition, it isrecognized that this test method may not be the only method todetermine and quantify extractables. This test method is also not intended to extract residue for usein biocompatibility testing. No other units of measurement are included in thisstandard. 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 health practices and determine the applica-bility of regulatory limitations prior to use. Referenced Documents2. Inclusive in this are oils, greases,hydrocarbons, and low molecular weight polymers.
Typicalsolvents used to dissolve these residues include chlorinated orfluorinated solvents, or low molecular weight hydrocarbons. It is designed to allowboiling of the solvent in the extraction vessel and to return anyvaporized solvent to the extraction vessel.
Current edition approved March 1, Published March Originallyapproved in Last previous edition approved in as F — United States Thisarea does not include the internal porosity of parts withcancellous, porous, or wire structure. Summary of Test Method4. The residues aregrouped into three categories: 1 water-soluble extractables; 2 non-water soluble extractables; and 3 non-soluble debris.
Significance and Use5. Extract-able residue includes aqueous and non-aqueous residue, as wellas non-soluble residue. Other techniques, such as solvent reflux extraction, could beused but have been shown to be less efficient in some tests, asdiscussed in X1. The bath must be largeenough to hold an extraction beaker containing the medicalcomponent. This apparatus is used with the technique de-scribed in Alternatively, an ultrasonic probe can be usedwith a bath.
This assembly is composed of a vessel large enough to hold themedical component, and a water-cooled refluxing column. Aheating manifold or hotplate stirrer capable of reaching theboiling point of the solvent is also included. This apparatus isused in the procedure described in A Soxhlet extractor, asshown in Fig. Additionally, metal beakers could be used. Plastic beakers should not be used as low molecular weightresidues could be extracted from the beakers.
Some solvents can leachextractable compounds from plastic pipets. Glass or metallicpipets are recommended for organic solvents. Reagents and Materials7. Severalsolvents may be required if more than one type of residue maybe present on the component. Sampling, Test Specimens, and Test Units9. Cutting lubricants must be avoided in this procedure.
Limits of Detection and Recovery Efficiency Limits of detection for the two extractiontechniques described in Section 11 can be assessed by placingknown amounts of residues on the test coupons, and perform-ing the extraction and analyses described in Section When using this method, the extraction efficiency E isthe ratio of the amount of recovered residue to the dopedamount of residue.
Recovery efficiency may also be deter-mined by exhaustive extraction. The exhaustive extractiontechnique uses medical components which have not beencleaned and contain unknown amounts of the target residue s. When using this approach, theextraction efficiency E is the ratio of the amount of recoveredresidue from the first extraction to the total amount ofrecovered residue from all extractions performed.
This stepshould be performed if target residues are known a priori. Inthe case of mixed residues, extraction efficiency may not beable to be determined. The extraction solvent may be used. It can dissolve in the solvent and contaminate thesolution. Polytetrafluoroethylene PTFE sleeves or tape can beused to seal the joints if necessary. The stir bar or boiling stones, or both, should becarefully cleaned in a suitable solvent prior to use.
The extractiontime or number of cycles can be adjusted by the user based oninternal validation of their target residue. Carefully open theapparatus. If a Soxhlet extractor is used, heavy debris may stayin the top part of the extractor. This debris can be washed downinto the collection vessel with fresh extraction solvent. The beaker should be weighed toa resolution of at least 0. Weigh the solution with beaker and foiland record as m4.
See X1. The solution weight m4is the sumof the aliquot weights plus the foil weight. The final beakerweight m5should be recorded as described in
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Bagis This standard does not purport to address all of the safety concerns, if any, associated with its use. There were no books found for the applied search filters. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability astn regulatory limitations prior to use.