Recognized standard

51276 Fourth edition 2019-08

FDA recognition 14-545 · ISO · Sterility

Key facts

Recognition number 14-545
Designation 51276 Fourth edition 2019-08
Title Practice for use of a polymethylmethacrylate dosimetry system
Standards developer International Organization for Standardization
Specialty area Sterility
Date of entry Jul 6, 2020
Scope (excerpt) 1.1 This is a practice for using polymethylmethacrylate (PMMA) dosimetry systems to measure absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. The PMMA dosimetry system is generally used as a routine dosimetry system. 1.2 The PMMA dosimeter is…

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