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These standards help to identify characteristics such as chemical content, acidity or alkalinity, tensile breaking strength, peel adhesion, and water, oil, and tear resistance among others.
Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure. Whitehouse Laboratories is happy to assist customers to better understand the testing, the available options and how to execute packaging validation projects on time and on budget.
We routinely execute many physical tests required by ISO 11607 on your sterile barrier packaging.
The package must keep a device sterile throughout all the stresses and hazards generated by the manufacturing, shipping, and storage environments.
Ultimately, any device that is labeled as sterile but arrives nonsterile at the point of use can critically compromise patient safety.
A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of: Medical devices vary according to their intended use and indications.