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> Learn about packaging standards and their importance in ensuring the safety and performance of medical devices over time.

Source: https://lso-inc.com/medical-package-testing/standards/

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# Packaging Standards for Medical Device Safety

[Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form)

![Packaging Standards for Medical Device Safety](https://lso-inc.com/api/media/file/Sterile-medical-packaging-and-components.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

Both the FDA and international regulatory bodies emphasize on compliance with ISO 11607; Packaging for Terminally Sterilized Medical Devices. This standard defines the test requirements necessary to ensure that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport, or storage.

-   **ANSI**  
    American National Standards Institute
-   **AAMI**  
    Association for the Advancement of Medical Instrumentation
-   **ASTM**  
    American Society for Testing & Materials
-   **ISO**  
    International Organization for Standardization
-   **ISTA**  
    International Safe Transit Association

  

-   [ASTM-D3078](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d3078/)
-   [ASTM-D4169](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d4169/)
-   [ASTM-D642](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d642/)
-   [ASTM-F1140](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1140/)
-   [ASTM-F1980](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1980/)
-   [ASTM-D4728](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d4728/)
-   [ASTM-D999](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d999/)
-   [ASTM-D6344](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d6344/)
-   [ASTM-D6653](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d6653/)
-   [ASTM-F1886](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1886/)
-   [ASTM-F2096](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f2096/)
-   [ASTM-D5276](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d5276/)
-   [ASTM-D4332](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-d4332/)
-   [ASTM-F1929](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f1929/)
-   [ASTM-F88](https://lso-inc.com/services/medical-package-testing/standards/astm-standards/astm-f88/)

-   [ISTA 1A](https://lso-inc.com/services/medical-package-testing/standards/ista-standards/ista-standard-1a/)
-   [ISTA 2A](https://lso-inc.com/services/medical-package-testing/standards/ista-standards/ista-standard-2a/)
-   [ISTA 3A](https://lso-inc.com/services/medical-package-testing/standards/ista-standards/ista-standard-3a/)
-   [ISTA 1G](https://lso-inc.com/services/medical-package-testing/standards/ista-standards/ista-standard-1g/)

-   [ISO 11607](https://lso-inc.com/services/medical-package-testing/standards/iso-11607-standards/)

## Standards Expertise

### Package Testing Standards Organizations

Life Science Outsourcing is experienced in package testing that must comply with the following standards:

### ASTM Standards

### ISTA Standards

• ISTA 1A • ISTA 2A • ISTA 3A • ISTA 1G Learn More

### ISO Standards

• ISO 11607 • ISO 17665 Learn More

## On this Page

## Ready to get started?

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