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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 14-405
Standard
ASTM  F2252/F2252M-13 (Reapproved 2018)
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
Scope/Abstract
1.1 This practice describes a means of evaluating ink or coating adhesion to flexible packaging materials. This practice is intended for use on flexible packaging materials whose surfaces are not damaged by the application and removal of tape.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where sterilization and packaging are components of the development and manufacture of the product.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Steven Turtil
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-6305
  steven.turtil@fda.hhs.gov
 Matthew Beckwith
  CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3393
  Matthew.Beckwith@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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