GSO ASTM F2459:2022
ASTM F2459:18
Gulf Standard
Current Edition
·
Approved on
12 May 2022
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
GSO ASTM F2459:2022 Files
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GSO ASTM F2459:2022 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.
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