# Medical Device Testing Standards Reference | ASTM, ISTA, ISO > Reference library for ASTM, ISTA, and ISO standards used in medical device packaging validation, transit testing, and sterilization. Explained by FDA-registered contract manufacturing engineers. Source: https://lso-inc.com/standards/ --- # Medical Device Standards Reference [Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) ![Medical Device Standards](https://lso-inc.com/api/media/file/MedicalDeviceStandards.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 ## Browse by Category [ ### ASTM Standards Packaging integrity, seal strength, and distribution simulation testing. 15 standards](https://lso-inc.com/standards/#astm)[ ### ISTA Standards Transit testing protocols for real-world shipping conditions. 8 standards](https://lso-inc.com/standards/#ista)[ ### Regulatory EU MDR deadlines, extensions, and compliance requirements. 1 standard](https://lso-inc.com/standards/#regulatory) ![ASTM International](https://lso-inc.com/api/media/file/astm_logo-1.png) ## ASTM Standards for Medical Device Packaging Testing standards for seal strength, packaging integrity, and distribution simulation under ISO 11607. [Seal strength vs. seal integrity →](https://lso-inc.com/seal-strength-vs-seal-integrity-testing/) [ASTM D3078 ### ASTM D3078: Key Aspects of Bubble Emission Discover ASTM D3078, the standard for detecting gross leaks in flexible packaging using a bubble emission test method. Read standard](https://lso-inc.com/standards/astm-standards/astm-d3078/) [ASTM D5276 ### ASTM D5276: Understanding Drop Test Methods Learn about ASTM D5276, a standard that assesses container integrity under shock impact from free falls. Read standard](https://lso-inc.com/standards/astm-standards/astm-d5276/) [ASTM D6344 ### ASTM D6344: Evaluating Packaging Impact Resistance Learn about ASTM D6344 and how it assesses the ability of packaging to protect contents from concentrated impacts. Read standard](https://lso-inc.com/standards/astm-standards/astm-d6344/) [ASTM D642 ### ASTM D642: Understanding Compressive Resistance Learn how ASTM D642 helps in testing the compressive resistance of shipping containers and their components for safe ... Read standard](https://lso-inc.com/standards/astm-standards/astm-d642/) [ASTM D6653 ### ASTM D6653: Understanding High Altitude Testing Learn how ASTM D6653 evaluates products and packaging effects during transport over high mountain passes and varying ... Read standard](https://lso-inc.com/standards/astm-standards/astm-d6653/) [ASTM D999 ### ASTM D999: Understanding Vibration Testing Standards Learn about ASTM D999 and how it helps minimize shipping container damage through effective vibration testing methods. Read standard](https://lso-inc.com/standards/astm-standards/astm-d999/) [ASTM F1140 ### ASTM F1140 Burst & Creep Test | Medical Packaging STM F1140 evaluates seal strength in flexible medical packaging using burst and creep pressurization to support ISO 1... Read standard](https://lso-inc.com/standards/astm-standards/astm-f1140/) [ASTM F1886 ### ASTM F1886 Visual Seal Inspection | Medical Device Packaging ASTM F1886 visual seal inspection for detecting visible defects in medical device packaging as part of ISO 11607 vali... Read standard](https://lso-inc.com/standards/astm-standards/astm-f1886/) [ASTM F1929 ### ASTM F1929 Dye Penetration Testing | Porous Packaging ASTM F1929 dye penetration testing for detecting channel leaks in porous medical device packaging under ISO 11607. Read standard](https://lso-inc.com/standards/astm-standards/astm-f1929/) [ASTM F2096 ### ASTM F2096 Bubble Leak Test | Medical Packaging ASTM F2096 explains how bubble leak testing detects gross leaks in sterile medical packaging to support ISO 11607 int... Read standard](https://lso-inc.com/standards/astm-standards/astm-f2096/) [ASTM D4169 ### ASTM-D4169 ASTM-D4169 describes the standard practice for performance testing of shipping containers and systems. Read standard](https://lso-inc.com/standards/astm-standards/astm-d4169/) [ASTM D4332 ### ASTM-D4332 ASTM-D4332 provides for conditioning atmospheres that are used prior to conducting transit simulation tests. Read standard](https://lso-inc.com/standards/astm-standards/astm-d4332/) [ASTM D4728 ### ASTM-D4728 Understand ASTM D4728 for shipping containers. This standard ensures accurate random vibration testing to minimize da... Read standard](https://lso-inc.com/standards/astm-standards/astm-d4728/) [ASTM F1980 ### ASTM-F1980 ASTM-F1980 provides documentation for developing accelerated aging protocols to promptly determine the effects, if an... Read standard](https://lso-inc.com/standards/astm-standards/astm-f1980/) [ASTM F88 ### ASTM-F88 ASTM F88 peel-test for flexible barrier seal strength—LSO delivers precise ASTM F88 seal integrity testing for compli... Read standard](https://lso-inc.com/standards/astm-standards/astm-f88/) [Get a Packaging Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) ![ISTA](https://lso-inc.com/api/media/file/ista_logo-300x300-2.png) ## ISTA Standards for Transit Testing Performance testing protocols that validate your packaging survives real-world shipping conditions. [ISTA 1A ### ISTA 1A Package Testing for Medical Devices ISTA 1A package testing evaluates basic distribution hazards for individually packaged medical devices. Learn when IS... Read standard](https://lso-inc.com/standards/ista-standards/ista-standard-1a/) [ISTA 1G ### ISTA 1G Package Testing for Medical Devices ISTA 1G package testing evaluates basic parcel delivery hazards for individually packaged medical devices. Learn when... Read standard](https://lso-inc.com/standards/ista-standards/ista-standard-1g/) [ISTA 2A ### ISTA 2A Testing | Medical Device Packaging ISTA 2A evaluates medical device packaging using discrete compression, vibration, and shock events for distribution p... Read standard](https://lso-inc.com/standards/ista-standards/ista-standard-2a/) [ISTA 3A ### ISTA 3A Testing for Medical Device Packaging Learn how ISTA 3A applies to medical device packaging and how LSO supports sterile barrier integrity and ISO 11607 co... Read standard](https://lso-inc.com/standards/ista-standards/ista-standard-3a/) [ISTA Standard 1A ### ISTA Standard 1A ISTA 1A is for packaged-products 150 lb. (68 kg) or less, and challenges the strength and robustness of the product a... Read standard](https://lso-inc.com/standards/ista-standard-1a/) [ISTA Standard 1G ### ISTA Standard 1G ISTA 1G is for packaged-products 150 lb. (68 kg) or less, and challenges the strength and robustness of the product a... Read standard](https://lso-inc.com/standards/ista-standard-1g/) [ISTA Standard 2A ### ISTA Standard 2A ISTA 2A tests are for packaged-products 150 lb. (68 kg) or less, and are a combination of basic test elements from IS... Read standard](https://lso-inc.com/standards/ista-standard-2a/) [ISTA Standard 3A ### ISTA Standard 3A ISTA 3A test is for packaged-products weighing 150 lb. (70 kg) or less, and is a general simulation test for individu... Read standard](https://lso-inc.com/standards/ista-standard-3a/) [Get a Packaging Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) ![ISO](https://lso-inc.com/api/media/file/iso_logo-1.png) ## Regulatory Standards & Directives Key regulatory frameworks and directives affecting medical device manufacturers. [EU MDR 2025–2028 Extension: Packaging & Testing Guidance ### EU MDR 2025–2028 Extension: Packaging & Testing Guidance Understand the EU MDR 2025–2028 extension. Learn new deadlines, legacy device rules, and packaging and sterilization ... Read standard](https://lso-inc.com/standards/eu-mdr-extension-2025-2028/) ## Need help determining which standards apply to your device? LSO's engineers can review your product and recommend the right test protocols. [Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) [Book a Sterilization Consult](https://lso-inc.com/solutions/sterilization-validation/#intake-form) Or call us directly: [(714) 672-1090](tel:7146721090)