Recognized standard

F1140/F1140M-13 (Reapproved 2020)e1

FDA recognition 14-402 · ASTM · Sterility

Key facts

Recognition number 14-402
Designation F1140/F1140M-13 (Reapproved 2020)e1
Title Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
Standards developer ASTM International
Specialty area Sterility
Date of entry Jan 30, 2014
Scope (excerpt) 1.1 These test methods explain the procedure for determining the ability of packages to withstand internal pressurization. 1.2 The burst test increasingly pressurizes the package until the package fails. 1.3 The creep test maintains a specified pressure for a specified time or until the package…

At a glance

  • None Product codes
  • 1–9 FDA guidance documents

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