ASTM F2459-12

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

SIGNIFICANCE AND USE
This test method is suitable for determination of the extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.
This test method recommends the use of a sonication technique to extract residue from the medical component. Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.2.
This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).
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 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 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.
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.

General Information

• Status: Historical
• Publication Date: 29-Feb-2012
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F2459-05 - Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• Effective Date: 01-Mar-2012
• Replaced By: ASTM F2459-18 - Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• Effective Date: 01-Feb-2018
• Referred By: ASTM F3335-20 - Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
• Effective Date: 01-Mar-2012
• Referred By: ASTM F3127-22 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• Effective Date: 01-Mar-2012
• Referred By: ASTM F2847-17 - Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• Effective Date: 01-Mar-2012
• Referred By: ASTM F3321-19 - Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 01-Mar-2012

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2459 − 12
Standard Test Method for
Extracting Residue from Metallic Medical Components and
1
Quantifying via Gravimetric Analysis
This standard is issued under the fixed designation F2459; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This test method covers the quantitative assessment of
2.1 ASTM Standards:
the amount of residue obtained from metallic medical compo-
E691 Practice for Conducting an Interlaboratory Study to
nents when extracted with aqueous or organic solvents.
Determine the Precision of a Test Method
G121 Practice for Preparation of Contaminated Test Cou-
1.2 This test method does not advocate an acceptable level
pons for the Evaluation of Cleaning Agents
of cleanliness. It identifies one technique to quantify extract-
G131 Practice for Cleaning of Materials and Components by
able residue on metallic medical components. In addition, it is
Ultrasonic Techniques
recognized that this test method may not be the only method to
G136 Practice for Determination of Soluble Residual Con-
determine and quantify extractables.
taminants in Materials by Ultrasonic Extraction
1.3 Although these methods may give the investigator a
3
2.2 ISO Standard:
means to compare the relative levels of component cleanliness,
ISO 10993–12 Biological Evaluation—Sample Preparation
it is recognized that some forms of component residue may not
and Reference Materials
be accounted for by these methods.
1.4 The applicability of these general gravimetric methods
3. Terminology
have been demonstrated by many literature reports; however,
3.1 Definitions:
the specific suitability for applications to all-metal medical
3.1.1 ionic compounds/water soluble residue—residue that
componentswillbevalidatedbyanInterlaboratoryStudy(ILS)
is soluble in water, including surfactants and salts.
conducted according to Practice E691.
3.1.2 non-soluble debris—residue including metals, organic
1.5 This test method is not intended to evaluate the residue
solids, inorganic solids, and ceramics.
level in medical components that have been cleaned for reuse.
This test method is also not intended to extract residue for use
3.1.3 non-water soluble residue—residuesolubleinsolvents
in biocompatibility testing.
other than water. Inclusive in this are oils, greases,
hydrocarbons, and low molecular weight polymers. Typical
NOTE 1—For extraction of samples intended for the biological evalu-
solvents used to dissolve these residues include chlorinated or
ation of devices or materials, refer to ISO 10993–12.
fluorinated solvents, or low molecular weight hydrocarbons.
1.6 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this 3.1.4 reflux system—an apparatus containing an extraction
standard.
vessel and a solvent return system. It is designed to allow
boiling of the solvent in the extraction vessel and to return any
1.7 This standard may involve hazardous or
vaporized solvent to the extraction vessel.
environmentally-restricted materials, operations, and equip-
ment. This standard does not purport to address all of the
3.1.5 reuse—the repeated or multiple use of any medical
safety concerns, if any, associated with its use. It is the
component (whether labeled SUD or reusable) with reprocess-
responsibility of the user of this standard to establish appro-
ing (cleaning, disinfection, or sterilization, or combination
priate safety and health practices and determine the applica-
thereof) between patient uses.
bility of regulatory limitations prior to use.
1 2
This test method is under the jurisdiction ofASTM Committee F04 on Medical For referenced ASTM standards, visit the ASTM website, www.astm.org, or
and Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved March 1, 2012. Published March 2012. Originally the ASTM website.
3
approved in 2005. Last previous edition approved in 2005 as F2459 – 05. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2459-12. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2459 − 12
3.1.6 single use component (SUD)—a disposable compo- medical component, and a water-cooled
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2459–05 Designation: F2459 – 12
Standard Test Method for
Extracting Residue from Metallic Medical Components and
1
Quantifying via Gravimetric Analysis
This standard is issued under the fixed designation F2459; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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 one technique to quantify extractable
residueonmetallicmedicalcomponents.Inaddition,itisrecognizedthatthistestmethodmaynotbetheonlymethodtodetermine
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.
1.6The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
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.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
G131 Practice for Cleaning of Materials and Components by Ultrasonic Techniques
G136 Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
3
2.2 ISO Standard:
ISO 10993–12 Biological Evaluation—Sample Preparation and Reference Materials
3. Terminology
3.1 Definitions:
3.1.1 ionic compounds/water soluble residue—residue that is soluble in water, including surfactants and salts.
3.1.2 non-soluble debris—residue including metals, organic solids, inorganic solids, and ceramics.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Aug. 1, 2005. Published August 2005. DOI: 10.1520/F2459-05.
Current edition approved March 1, 2012. Published March 2012. Originally approved in 2005. Last previous edition approved in 2005 as F2459 – 05. DOI:
10.1520/F2459-12.
2
Forextractionofsamplesintendedforthebiologicalevaluationofdevicesormaterials,refertoISO10993-12BiologicalEvaluation—SamplePreparationandReference
Materials.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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