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ASTM F 2459 Document Information:
Title
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
ASTM International
Publication Date:
Aug 1, 2005
Scope:
This test method covers the quantitative assessment of the amount of
residue obtained from metallic
medical components when extracted with aqueous or organic solvents.
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.
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.
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 E 691.
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.(Footnote 2)
The values stated in SI units are to be regarded as the standard. The
values given in parentheses
are for information only.
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.
Footnote 2 - For extraction of samples intended for the biological
evaluation of devices or
materials, refer to ISO 10993-12 Biological Evaluation - Sample
Preparation and Reference
Materials.
Keywords:
- extractable residue
- gravimetric analysis
- metallic medical components
- non-soluble extractables
- non-soluble debris
- water soluble extractables
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