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IoPP Medical Device Packaging Committee
Industry Standards and Regulatory Update
• The following new standards are now available:
• New Items Current Balloted
• 5 yr. Resubmissions
• Balloted Revisions
• Task Group Activity
• 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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