ASTM F2847-26

1.1 The purpose of this practice is to describe how to report the cleanliness of single-use medical devices such as implants, and single-use sterile instruments as manufactured.

1.2 This practice proposes how to approach the identification of critical compounds and suggests analytical methods.

1.3 The practice does not address substances which are intrinsic to the medical device properties or design. It does not address substances released during device degradation (active/passive), from coatings, or leachables by design.

1.4 This practice applies to manufacturing contact materials, environmental contaminants, and contaminants from logistics processes.

1.5 This practice does not address the cleanliness of single-use medical devices which are re-processed, nor does it address reusable medical devices which are processed in the hospital, by the manufacturer, or by a third party.

1.6 This practice does not establish limit values for residues.

1.7 This practice suggests appropriate test methods for the general specification of residues and residue requirements of medical devices and single-use sterile instruments. This practice may also be used for reporting the cleanliness of semi-finished components for medical devices.

1.8 The test methods suggested and described herein refer to established analytical methods and to existing standard methods for chemical, biochemical, or biological analysis.

1.9 This practice is intended to provide guidance regarding suitable test methods and reporting conventions for residues, which may or may not affect medical device biocompatibility or device functionality. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F748 or in the ISO 10993 series.

1.10 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.

1.11 This 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.

5.1 The quality and, consequently, the clinical performance of medical devices may be affected by residues. Residues on single-use medical devices, as well as on single-use sterile instruments, may induce minor tissue irritations, or they may lead to local inflammation of tissues surrounding the surgical area or the implant which may lead to failure in short-term or long-term use of the medical device or prolong healing time. Residues may also cause systemic harm or harm to tissues not local to the surgical area and implant. Residues may originate from manufacturing materials used in the course of processing or from the manufacturing environment, or may be the result of handling and packaging (1-3).

5.2 This practice shall be used to report the results of testing for residue. It suggests standard techniques that may be applied for analysis of specific classes of residues.

5.3 Residues may be of inorganic, organic, or biological nature. They may exhibit as surface-bound substance, or as adsorbates (for example, electrostatically held), efflorescence, or mechanically held substances. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

5.4 Data generated in validation processes (that is, cleaning validation or sterility validation) may be used as results or as basis for setting acceptance criteria in the report.

5.5 This standard provides suggestions for how limit values may be established.

5.6 It is important to note that some residues are difficult to detect, identify, or quantify irrespective of analytical methods.