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ASTM F 2459 : 2018

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-02-2018

€56.53
Excluding VAT

This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents.

Committee
F 04
DocumentType
Test Method
Pages
8
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents.

1.2This 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.

1.3Although 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.

1.4The 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.

1.5This 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.

1.6The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.8This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F 2847 : 2017 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
ASTM F 3127 : 2016 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

ASTM G 136 : 2003 : R2016 : EDT 1 Standard Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
ASTM G 131 : 1996 : R2023 : EDT 1 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
ASTM G 136 : 2003 : R2023 : EDT 1 Standard Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2023 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM G 131 : 1996 : R2016 : EDT 1 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques

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