• Healthcare Equipment
  • Regulations


Is your company ready for the heavier release tests of your Medical equipment packaging? ISTA 3 packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market. Nefab is ready for this, with our global coverage of ISTA certified test labs and our engineers can apply the right packaging design choices. So that the packaging is in line with this new regulation and can pass these rigorous test standards.

Medical Device Packaging

The package of a medical device will play a fundamental role in the safe delivery of treatment to patients. It needs to ensure the integrity of the product from the manufacturer to its final point of use, and in some cases, the packaging could function in the treatment application. For these reasons, it is important that medical device manufacturers choose the proper packaging in order to prevent mechanical damage during transit.

While medical technology packaging certainly needs to protect high-value products during shipping and transport, it must also comply with health and safety regulations. At Nefab, we use ISTA testing, which is recognized by the U.S. Food and Drug Administration (FDA) as approved standards for medical device packaging. We work tirelessly to ensure that your packaging is in line with these new regulations and are fit to pass the FDA’s rigorous testing standards.

U.S. FDA Requirements for Medical Device Packaging

The FDA is the U.S. regulatory agency responsible for protecting public health by ensuring food and drug safety. In particular, they regulate all medical devices and radiation-emitting products that enter – and leave – the United States. Any medical or radiation-emitting device that is used, produced in, or imported to the U.S. is required to have a packaging release test completed in a certified lab – including our state-of-the-art Nefab facilities. These tests prove that the medical device packaging is fit to withstand transport and handling and will adequately protect the packaged product.

The FDA Accepts International Safe Transit Association (ISTA) Standards
The International Safe Transit Association (ISTA) has authored a variety of testing procedures that define proper package performance and how to best protect package contents. The ISTA’s industry testing standards are trusted worldwide and inform global manufacturers on how to best protect their products when shipping in an unpredictable global transportation environment. Now accepted by the FDA, the ISTA began its package performance testing more than 60 years ago, and it is one of the most knowledgeable and respected authorities in the field of package-performance testing. Recently, the FDA added the tougher ISTA 3 packaging and transport standards as the official standards for all medical device and radiation emitting machines packaging in the U.S. market. At Nefab, we have fully adopted these standards for all of our packaging solutions, and our global ISTA-certified test labs work hard to apply the proper packaging design for our customers.

ISTA 3 Testing for Medical Devices

At Nefab, we conduct a variety of ISTA tests in order to ensure our medical device manufacturer customers have selected the proper packaging solution. The ISTA 3 standards are some of the toughest used tests for medical devices, as they include full simulations of the damaging-producing events that could occur during the transport environment.

The ISTA3A, B or E are full simulations 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. This will include intense vibration to simulate transport of months in only a few hours, Multiple drops that range from 0,2 to 1meter or atmospheric conditioning such as frozen (-29°C or -20°F) or high temperature (+60°C or 140°F) and moisture levels (85% RH).

ISTA 3A Testing
ISTA 3A tests are designed to provide laboratory simulations of the potentially hazardous conditions, forces, and motions of a transport environment. These tests are applicable across a variety of circumstances, including different routes, vehicle types, and handling exposures. Used for packaged products weighing 150 pounds or less, this general simulation test will examine how a package withstands vibration, different drop heights, and various atmospheric conditions, including winter/frozen and tropical wet weather. These tests are appropriate for standard, elongated, flat, or small packages that are distributed as individual parcels.

ISTA 3B Testing
Procedure 3B involves simulation testing for packaged products that will be shipped via a truck system. The same load may contain different types of products, often from different manufactures and intended for different destinations. These procedures test for a variety of factors, including: Shock (rotational drop, free-fall drop, tip over, impact, forklift handling), Rotational drop, Vertical vibration, Atmospheric conditioning – humidity and temperature changes.

ISTA 3E Testing
Test Procedure 3E is also a general simulation test, but it is used for unitized loads of the same packaged products. Unitized loads contain one or more products, typically on a pallet or skid, that are secured together as a single load. 3E testing can be used to: Evaluate the stability of the load, Determine the protective performance of packaging and packaged-products in relation to shock, vibration, and other stresses, Evaluate some conditions of transit, including pressure, moisture, and unusual handling.
It is important to remember that the product and package are considered together rather than separately with 3E testing.

"Nefab Offers Cost Effective Solutions for Regulatory Compliance"

Nefab’s Certified Testing Labs

For years, Nefab has been a frontrunner in the development of medical device packaging solutions that comply with regulatory standards. While we appreciate the importance of these regulations, we also understand that our customers need packaging solutions that are cost effective and good for their brand. In addition to our in-depth knowledge of all medical device industry requirements, we also provide value to our customers in several ways:
Reduced overall costs. The correct packaging solution can reduce the weight of your product, requiring less materials overall and reducing your costs.
Environment optimization. Many clients hoe to reduce their environmental impact. At Nefab, we can create packaging solutions that will greatly reduce your carbon footprint.
Reduced shipping damage and optimal product protection. The right packaging solution will get your product to its final destination safely. At Nefab, we work to minimize shipping damage and associated costs.

We are standing by and ready to help you ship your medical devices safely 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.

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