# ASTM Standards for Medical Package Testing Explained > Explore the importance of ASTM standards in medical package testing and their impact on quality in the life sciences industry. Source: https://lso-inc.com/standards/astm-standards/ --- # ASTM Standards [Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) [Explore Standards](https://lso-inc.com/standards/) ![ASTM standards for global testing compliance](https://lso-inc.com/api/media/file/ASTM%20standards%20for%20global%20testing%20compliance.webp) FDA-Registered Manufacturing Facility ISO 13485 Certified Quality System 12 Cleanrooms Class 5–8 125,000+ Sq Ft Regulated Manufacturing 3 Facilities CA | NH | Costa Rica ISO 17025 Accredited Packaging Lab Life Science Outsourcing is an industry-leading expert in medical package testing that complies with all required ASTM International standards. ## ASTM Standards Expertise ASTM International, originally known as the American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. ASTM has a dominant role among standards developers in the USA and is considered to be the world’s largest developer of standards. While it cannot enforce its standards, government authority can make them mandatory. Using a consensus process, ASTM supports thousands of volunteer technical committees, which draw their members from around the world and collectively develop and maintain more than 12,000 standards. ## Categories of ASTM International Standards - **Standard Specification** defines requirements to be satisfied by subject of the standard. - **Standard Test Method** defines the way a test is performed. The result of the test may be used to assess compliance with a specification. - **Standard Practice** defines a sequence of operations that, unlike a test, does not produce a result. - **Standard Guide** provides an organized collection of information or series of options that does not recommend a specific course of action. - **Standard Classification** 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 D Standards #### ASTM D-10 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. - [**ASTM-D3078**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d3078/) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission - [**ASTM-D4169**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d4169/) Standard Practice for Performance Testing of Shipping Containers and Systems - [**ASTM-D4728**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d4728/) Standard Test Method for Random Vibration Testing of Shipping Containers - [**ASTM-D4332**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d4332/) Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing - [**ASTM-D5276**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d5276/) Standard Test Method for Drop Test of Loaded Containers by Free Fall - [**ASTM-D642**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d642/) Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads - [**ASTM-D999**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d999/) Standard Test Methods for Vibration Testing of Shipping Containers - [**ASTM-D6344**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d6344/) Standard Test Method for Concentrated Impacts to Transport Packages - [**ASTM-D6653**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d6653/) Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method ### ASTM – F Standards #### 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. - [**ASTM-F1140**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1140/) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages - [**ASTM-F1929**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1929/) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - [**ASTM-F1980**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1980/) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices - [**ASTM-F1886**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1886/) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection - [**ASTM-F88**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f88/) Standard Test Method for Seal Strength of Flexible Barrier Materials (Peel Test) - [**ASTM-F2096**](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f2096/) Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble) ## Need testing or validation support? 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