Medical device packaging standards will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients.  For these reasons, it is important to choose the proper packaging to ensure the integrity of the product and to prevent damages during the distribution cycle.

Thus, medical device manufacturer has to face with medical device packaging requirements to protect high-value products and must also comply with health and safety regulations. At this point, packaging validation requirements for medical devices are so important in order to comply with the approved standards for medical device packaging. Well-designed packaging is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards.

Improperly designed and validated packaging can even derail a product. A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes, tears and broken seals, it also has to withstand sitting on a shelf, possibly for years, without breaking down.

The proper selection of packaging will ensure the integrity of the product and prevent damages during the distribution cycle.


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Which medical device packaging standards are on the market right now

There are few medical packaging standards on the market that fits the requirements of the Medical Devices Regulation (MDR) of the European Union and the U.S. Food and Drug Administration (FDA) in the U.S.

The type of regulations that apply will depend on the kind of device and due to of the kind of packaging used to protect it. Some of the standards for packaging are:

  • ISO 11607 Packaging for terminally sterilized medical devices
  • EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods
  • ASTM F1585 Guide for Integrity Testing of Porous Medical Packages
  • ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
  • ASTM F2475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
  • BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
  • ISTA 3 packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market.


Medical device packaging requirements: ensuring your material

Package testing requirements

Package validation testing for medical devices are described in ISO 11607. Test aims to validate the integrity of the material (bubble leak), the integrity of the seal (resistance of the seal), the distribution tests and the aging of the package.

This part of the process is the longer one, can vary from one month to six months, depending on the desired useful life of the medical device.

At the end, before any testing, the final packaging must be sterilized,  as it would be in real life, before it is submitted to the packaging test.

  • ISO 11607-1 specifies the requirements for materials and test methods, pre-formed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.

For sterile barrier packaging systems, ISO 11607 Part 1 outlines four key requirements:

  • ISO 11607 Stability Testing: Real Time Aging and Accelerated Aging (ASTM F1980) to demonstrate the sterile barrier system maintains integrity over time for the anticipated shelf life of the product.
    • Accelerated Aging (ASTM F1980)
    • Real-time Aging (A requirement to backup an accelerated aging study)
  • ISO 11607 Performance Testing: ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage.
    • ISTA Procedures 1, 2, 3
    • ASTM D642 Determining Compressive Resistance of Shipping Containers, Components and Unit Loads
    • ASTM D695 Compressive Properties of Rigid Plastics
    • ASTM D1621 Compressive Properties of Rigid Cellular Plastics
    • ASTM D4169 Performance Testing of Shipping Containers and Systems
  • ISO 11607 Package Strength Testing: Physical tests to demonstrate the mechanical performance of the sterile barrier system. ASTM Packaging Strength Testing Standards are:
    • ASTM D3330 Package Strength Testing by Peel Adhesion Testing
    • ASTM F88 Package Strength Testing by Seal Peel Testing
    • ASTM F1140 Package Strength Testing by Burst Testing
    • ASTM F2054 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
  • ISO 11607 Package Integrity Testing: Physical tests to demonstrate the sterility and integrity of the sterile barrier system.
    • Package Integrity (ASTM F2096: Bubble Test)
    • Seal Integrity (ASTM F1886: Visual Inspection, ASTM 1929: Dye Test)
    • Seal Strength (ASTM F88: Peel Test, ASTM F1140: Burst Test)


You might be interested in: ASTM D4169: standards and procedures


This ISO standard also addresses packaging materials by presenting requirements for their physical properties and material performance.

  • ISO 11607-2 specifies the requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include the forming, sealing, and assembly of preformed sterile barrier systems, the sterile barrier systems themselves and the packaging systems.

It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.


Load stability guide


Other packaging validation requirements for medical devices

All medical device materials and products have a finite life span due to the degradation of the material that occurs over time. That’s why packaging systems require validation programs to test the degradation. This procedure is generally called accelerated aging.

In addition to the processes described on ISO 11607-1, transportation and warehouse storage affect medical device packaging state.

Packaging testing guidelines are listed in ISO 11607. This guide brings together many key aspects of packaging validation like the material qualification, validation of seal process, whole package seal integrity. Also include physical tests to be performed such as burst, creep, creep to fail, peel, and leak tests.  

The final aspect of the validation process for medical device packaging systems consists of the evaluation of the packaging system’s performance during transportation, distribution and storage.

Evaluation of transportation may encompass three different types of testing:

The first type of testing is ISTA 1 Series: Non-Simulation Integrity Performance Tests. Challenge the strength and robustness of the product and package combination. Not designed to simulate environmental occurrences. Useful as screening tests, particularly when used as a consistent benchmark over time.

The second testing type is described in ISTA’ Serie 2 and Serie 3, as well as in ASTM D 4169, General simulation performance testing is intended to simulate the conditions encountered throughout the complete transportation chain.

  • ISTA 2 Series: Partial Simulation Performance Tests. Tests with at least one element of a 3 Series type General Simulation performance test, such as atmospheric conditioning or mode-shaped random vibration, in addition to basic elements of a 1 Series type Non-Simulation Integrity test.
  • ISTA 3 Series: General Simulation Performance Tests. Designed to provide a laboratory simulation of the damage-producing motions, forces, conditions, and sequences of transport environments. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. Characteristics will include simple shaped random vibration, different drop heights applied to the sample package, and/or atmospheric conditioning such as tropical wet or winter/frozen.
  • ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems


Continue reading: Ista 1a, Ista 2a, Ista 3a procedures: all you need to know


A third testing type is a custom test procedure. This focus simulation uses the collected data for a real transport distribution cycle for a specific type of transport.

As a result, focused simulation is used to assess the performance of packaging under specific transportation or storage conditions. Depending on the type of packaging materials, test models used in evaluating packaging systems during transportation, distribution and storage may include compression testing, shock testing, vibration testing, impact testing and testing under climatic exposure.

The objective of this set of tests is to inspect the packaging systems for any damage that may have resulted. Additionally, testing to assess the integrity of packaging during transportation and storage can lead to modification of the packaging system.

A better packaging design and a better material selection can stabilize the medical device and increase protection. Thus, transportation testing is a necessary component of an evaluation program for medical devices.

Then, is fundamental an effective packaging to preserve the sterility and the properties of the medical devices. A good design and a validation process are fundamental to provide customers and medical organizations with high-quality medical devices.

Furthermore, this process will help to avoid costly mistakes due to a bad selection of packaging materials and incorrect packaging design, that could compromise the medical device during storage and transportation.  

As a result, appropriate testing procedures that meet the requirements of the governing agencies, the Food and Drug Administration (FDA) and/ or Medical Device Directives of the European Union are mandatory to ensure the integrity of the product and to comply with the medical device packaging standards.

The team of Safe Load Testing Technologies is ready to help you to choose the best solutions for designing your medical devices to ensure the integrity of the product and to prevent damages during the distribution cycle, while complying with government requirements.

Contact us today, and let our experienced team of engineers create a packaging solution that will work best for your business.

eumos 40509:2020