Originally Published PMPN
November 2003
Anniversary Special
ASTM Wraps Up Medical Device Packaging Standards|
Return to article: PMP News: Ten Years of Shelf Life |
The past decade has witnessed the growth of ASTM Subcommittee F02.60 for medical packaging plus many new methods for the packaging engineer. Curt Larsen and John Spitzley point out key ASTM “tools.”
F1585-00 Standard Guide for Integrity Testing of Porous Barrier Medical Packages.
F1608-00 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method).
F1886-98 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection.
F1929-98 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye
Penetration.
F1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages.
F2054-00 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates.
F2095-01 Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages with and without Restraining Plates.
F2096-01 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test).
F2097-01 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products.
F2203-02 (E01) Standard Test Method for Linear Measurement Using Precision Steel Rule.
F2217-02 Standard Practice for Coating/Adhesive Weight Determination.
F2227-02 Standard Test Method for Non-Destructive Detection of Leaks in Non-Sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method.
F2228-02 Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging which Incorporates Porous Barrier Material by CO2 Tracer Gas Method.
F2251-03 Standard Test Method for Thickness Measurement of Flexible Packaging Material.
Pending ASTM Test Method Vacuum Decay Test for Leaks in Porous and Non-Porous Packaging.
Copyright ©2003 Pharmaceutical & Medical Packaging News
