EUROLAB laboratory provides testing and compliance services within the scope of ASTM F2459 standard. The ASTM F2459 standard covers the quantitative assessment of the amount of residue obtained from metallic medicinal components when extracted with aqueous or organic solvents. This test method does not advocate an acceptable level of cleanliness.
It describes two techniques for measuring the amount of extractable residue on metallic medicinal components. In addition, it is recognized that this test method may not be the only method for determining and measuring extractables.
While these methods may provide the researcher with a means to compare relative component cleanliness levels, it is recognized that some forms of component residue cannot be explained by these methods.
The applicability of these general gravimetric methods has been demonstrated by many literature reports; however, specific suitability for applications for all metal medical components will be verified by an Interlaboratory Study (ILS) conducted according to Application E691.
This test method is not intended to assess the level of residue in medical components that have been cleared for reuse. This test method is also not intended to remove residue for use in biocompatibility testing. ISO 10993–12 should be consulted for extraction of samples for biological evaluation of devices or materials.
Values stated in SI units should be accepted as standard. No other units of measurement are included in this standard.
This standard may contain hazardous or environmentally restricted materials, processes and equipment. This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.
Our organization, EUROLAB, provides test method services for residue removal from metallic medical components and quantification through gravimetric analysis, within the framework of national and international standards, with its trained and expert staff and advanced technological equipment, among numerous test, measurement, analysis and evaluation studies. Provides testing services within the scope of ASTM F2459 standard.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
