Recognized standard

F2054/F2054M-13 (Reapproved 2020)

FDA recognition 14-403 · ASTM · Sterility

Key facts

Recognition number 14-403
Designation F2054/F2054M-13 (Reapproved 2020)
Title Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
Standards developer ASTM International
Specialty area Sterility
Date of entry Jan 30, 2014
Scope (excerpt) 1.1 These test methods cover the procedure for determining the minimum burst strength of a seal placed around the perimeter of a flexible package as it is internally pressurized and enclosed within restraining plates. 1.2 The test methods described herein are functionally similar to Test Methods…

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