Recognized standard

F2217/F2217M-13 (Reapproved 2018)

FDA recognition 14-401 · ASTM · Sterility

Key facts

Recognition number 14-401
Designation F2217/F2217M-13 (Reapproved 2018)
Title Standard Practice for Coating/Adhesive Weight Determination
Standards developer ASTM International
Specialty area Sterility
Date of entry Jan 30, 2014
Scope (excerpt) 1.1 This practice covers a procedure for determining the amount of coating applied to a substrate, (for example, film, paper, nonwoven). The amount of coating is expressed as a weight per given area, (for example, g/m2, lb/ream).

At a glance

  • None Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards