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Significance and Use
This test method is suitable for determination of the extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.
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.
This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).
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 one technique 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
G131 Practice for Cleaning of Materials and Components by Ultrasonic Techniques
G136 Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
ISO StandardISO10993–12 Biological Evaluation--Sample Preparation and Reference Materials
ICS Number Code 11.100.99 (Other standards related to laboratory medicine)