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.