Industry Standards and Regulatory Update

IoPP Medical Device Packaging Committee

Industry Standards and Regulatory Update



The following new standards are now available:

  • F2252 Ink/Coating Adhesion
  • F2250 Chemical/Alcohol Resistance to Inks
  • F2338 Nondestructive Vacuum Decay

New Items Current Balloted

  • Aerosol Filtration Using Particle Counters
  • Helium Leak Testing

5 yr. Resubmissions

  • F1886 Visual Inspection
  • F1929 Dye Penetration

Balloted Revisions

  • F2096 Internal Pressurization (Bubble Test)

Task Group Activity

  • Biocompatibility Guide
  • Airborne Ultrasound
  • Hydrostatic Head
  • Pouch Specification Guide
  • Abrasion Testing
  • Updating F2097 Design Guide
  • EN868 series test methods


• ISO 11607-1 and -2 are in preparation for balloting as a Draft International Standard (DIS) after CD comment resolution occurred at the December TC 198 meeting in New Orleans. CEN will parallel ballot these standards as EN/ISO standards.


• Project 4AB Alpha Test

• Project 3A Parcel Delivery Shipments



• CDRH Recognized Consensus Standards include ANSI/SSMI ISO11607:2000

• Bar Code Regulation



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