ISTA Standards
ISTA Standards LSO What Are ISTA Packaging Testing Standards? The International Safe Transit Association (ISTA) develops globally recognized test procedures used to evaluate how packaged products perform during distribution. ISTA testing simulates common shipping hazards such as vibration, shock, compression, and handling to assess whether packaging systems adequately protect products during transport. For medical device […]
ASTM-F2096
ASTM-F2096 LSO ASTM F2096 Bubble Leak Testing for Medical Device Packaging ASTM F2096 is the standard method for detecting gross leaks in sterile medical device packaging using pressurization and bubble emission. The test identifies holes, channels, and seal failures by submerging the package in water under controlled inflation. It is widely used to verify sterile […]
ASTM-F88
ASTM-F88 LSO / Medical Package Testing (MPT) / Medical Package Testing Standards / ASTM – F Standards / ASTM-F88 ASTM F88 Seal Strength Testing for Medical Device Packaging ASTM F88 / F88M is the industry-standard test method for measuring seal strength in flexible sterile barrier systems. It confirms the mechanical integrity of a package seal […]
ASTM-F1886
ASTM-F1886 LSO ASTM F1886 Visual Seal Inspection for Medical Device Packaging ASTM F1886 is a visual inspection method used to detect seal defects in medical device packaging. The method evaluates packages in two ways: 1) observes the seals for anomalies such as incomplete seals, channels, wrinkles, delamination, and foreign material, and 2) observes the surface […]
ASTM-F1980
ASTM-F1980 LSO ASTM F1980 Accelerated Aging for Medical Device Packaging ASTM F1980 is the recognized standard for accelerated aging of sterile medical device packaging. The standard defines methods for using elevated temperatures to simulate the effects of long-term storage on packaging systems, supporting initial shelf-life claims prior to real-time aging data. ASTM F1980 is commonly used […]
ASTM-F1929
ASTM-F1929 LSO ASTM F1929 Dye Penetration Testing for Medical Device Packaging ASTM F1929 is a qualitative package integrity test used to detect unsealed areas in porous medical device packaging seals. The method applies a colored dye solution to the package seal area and visually evaluates whether the dye penetrates through defects in the seal. ASTM […]
ASTM-F1140
ASTM-F1140 LSO ASTM F1140 Burst and Creep Testing for Medical Device Packaging ASTM F1140 defines the methods used to evaluate the strength and integrity of flexible medical packaging by applying internal pressurization until a seal or material failure occurs. Burst and creep tests help determine the weakest area of the packaging and what pressure is […]
ASTM – F Standards
ASTM – F Standards LSO ASTM International, originally known as the American Society for Testing and Materials (ASTM), was formed over a century ago. As the century progressed and new industrial, governmental and environmental developments created new standardization requirements, ASTM answered the call with consensus standards that have made products and services safer, better and […]
ASTM D6344
ASTM D6344 LSO Standard Test Method for Concentrated Impacts to Transport Packages The ASTM D6344 standard is intended to evaluate the ability of packaging to resist the force of concentrated impacts from outside sources, such as those encountered in various modes of transportation and handling. This test method is intended to determine the ability of […]
ASTM D6653
ASTM D6653 LSO Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method The ASTM D6653 test determines the effects of high altitude / pressure differential when packaged products are transported via certain modes of transport, such as aircraft or ground over high mountain passes. When exposed to these […]