ASTM-F2459 2012

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F2459-12 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

Published By	Publication Date	Number of Pages
ASTM	2012	7

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Categories: 11.100.99 - Other standards related to laboratory medicine, ASTM

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Description

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 1For 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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Summary of Test Method Significance and Use Apparatus Reagents and Materials Hazards Sampling, Test Specimens, and Test Units
3	Limits of Detection and Recovery Efficiency Procedure FIG. 1
4	FIG. 2
5	Calculation or Interpretation of Results Additional Analysis Report Precision and Bias
6	Keywords X1. RATIONALE AND NOTES ON EXTRACTION PROTOCOL X1.1 Rationale X1.2 Notes on Extraction Protocol

Additional information

Standard Title	F2459-12 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
Published Code	ASTM
Publication Date	2012
Pages Count	7
ICS Codes	11.100.99 - Other standards related to laboratory medicine

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ASTM-F2459 2012

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