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 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 E 691.

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.

1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

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

ISO Standard

Keywords

extractable residue; gravimetric analysis; metallic medical components; non-soluble extractables; non-soluble debris; water soluble extractables; Gravimetric determination; Medical devices/equipment; Quantitative analysis/measurement; Residue; Water-soluble extractable residue

ICS Code

ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

DOI: 10.1520/F2459-05

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