Significance and Use 5.1 This test method is suitable for determination of the total amount of extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. 5.2 This test method recommends the use of a sonication technique to extract residue from the medical component. Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.2. 5.3 This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).Scope 1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents. 1.2 This test method does not advocate an acceptable level of cleanliness. It identifies two techniques to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. 1.3 Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods. 1.4 The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the specific suitability for applications to all-metal medical components will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691. 1.5 This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing. Note 1: For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO 10993–12. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 This standard may involve hazardous or environmentally-restricted materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1375 - Demolition Materials (549) 1377 - Cartridge and Propellant Actuated Devices and Components (524) 4720 - Hose and Flexible Tubing (552) 4730 - Hose, Pipe, Tube, Lubrication, and Railing Fittings (1823) 5120 - Hand Tools, Nonedged, Nonpowered (1124) 5305 - Screws (781) 5306 - Bolts (996) 5310 - Nuts and Washers (864) 5330 - Packing and Gasket Materials (583) 5340 - Hardware, Commercial (953) 5905 - Resistor (753) 5910 - Capacitors (783) 5930 - Switches (1012) 5935 - Connectors, Electrical (4357) 5940 - Lugs, Terminals, and Terminal Strips (564) 5945 - Relays and Solenoids (733) 5950 - Coils and Transformers (856) 5960 - Electron Tubes and Associated Hardware (1630) 5961 - Semiconductor Devices and Associated Hardware (707) 6145 - Wire and Cable, Electrical (1629) 6240 - Electric Lamps (662) 6505 - Drugs and Biologicals (1343) 6515 - Medical and Surgical Instruments, Equipment, and Supplies (1907) 6520 - Dental Instruments, Equipment, and Supplies (790) 6530 - Hospital Furniture, Equipment, Utensils, and Supplies (745) 6610 - Flight Instruments (540) 6625 - Electrical and Electronic Properties Measuring and Testing Instruments (1241) 6640 - Laboratory Equipment and Supplies (1187) 6810 - Chemicals (1114) 8010 - Paints, Dopes, Varnishes, and Related Products (2046) 8030 - Preservative and Sealing Compounds (554) 8140 - Ammunition and Nuclear Ordnance Boxes, Packages and Special Containers (797) 8305 - Textile Fabrics (910) 8415 - Clothing, Special Purpose (660) 8455 - Badges and Insignia (3093) 8915 - Fruits and Vegetables (531) 9330 - Plastics Fabricated Materials (759) FACR (1647) ISDA (1776) ISDD (786) ISDF (1827) ISDN (581) MISC (1045) PACK (539) SESS (581)
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