Your Guide to ASTM F2847

ASTM F2847 establishes guidelines for reporting the cleanliness of single-use implants and single-use sterile instruments. The ASTM also suggests a variety of analytical test methods that can be used for the identification and specification of critical compounds, residues, and residue requirements.

The standard was revised in 2017 (ASTM F2847-17) and contained a number of updates related to new reference documentation and standards. These updates provide additional guidance related to quantification limits and precision, extraction methods, and total carbon determination.

See table 1 for a summary of standard and reference documentation added to and removed from ASTM 2847-17 changes

Table 1. ASTM 2847-17 reference documentation changes. (+ added, - removed)