ASTM – F Standards
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 more cost-effective.
Today, ASTM continues to play a leadership role in addressing the standardization needs of the global marketplace. ASTM International is one of the largest voluntary standards development organizations in the world – a trusted source for technical standards for materials, products, systems, and services. ASTM has a dominant role among standards developers in the USA, and claims to be the world’s largest developer of standards. In 2009, a joint effort by standards development organizations AAMI, ANSI, ASTM, and DIN created a single, centralized database for medical device standards.
The standards produced by ASTM International fall into six categories:
- Standard Specification that defines the requirements to be satisfied by subject of the standard.
- Standard Test Method that defines the way a test is performed. The result of the test may be used to assess compliance with a Specification.
- Standard Practice that defines a sequence of operations that, unlike a test, does not produce a result.
- Standard Guide that provides an organized collection of information or series of options that does not recommend a specific course of action.
- Standard Classification that provides an arrangement or division of materials, products, systems, or services into groups based on similar characteristics such as origin, composition, properties, or use.
ASTM F-02 Committee’s Scope:
The ASTM F-02 Committee’s responsibilities include the development of terminology, test methods, practices, and specifications for flexible barrier packaging, and the promotion of research in this field. Standards under the jurisdiction of other committees shall be used when applicable.
The area of interest of the committee is flexible barrier packaging including the component barrier materials, their properties, and package design, development and production. Flexible barrier packaging for the purpose of this Committee includes any package with at least one flexible component that can be bent or folded back upon itself. Typical flexible barrier materials are papers, nonwovens, plastic films, and metal foils, used alone, treated or in various combinations.
- Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
- Standard Test Method for Seal Strength of Flexible Barrier Materials (Peel Test)
- Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble