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Published 2016.12.02

FDA packaging release tests get tougher!

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.

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

Read more about the ISTA 3 packaging and transport standards in our Insight article