General device labeling 21 cfr part 801 use of symbols.
Medical device packaging equipment.
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.
Packaging for terminally sterilized medical devices published in 2006 is the principal reference guide for medical device packaging and includes information on testing requirements.
This article is in follow up to sterilization methods for medical device packaging packaging insights newsletter july 25 2016.
Neil thompson is business development manager of steriliant llc a one stop shop for medical device companies packaging needs.
Started by experienced medical device engineers and project managers steriliant provides packaging design material and equipment procurement protocol and report writing and contract manufacturing sourcing.
The medical device market is right in the sweet spot of making the most of our expertise in compliance and our turnkey solutions in packaging systems.
Medical device packaging must allow its contents to be sterilized and then must maintain that sterility until the time of use all while optimally balancing the multitude of considerations that are part of the package development process.
From dental devices to post partum medical supplies viking masek has a flexible packaging solution to increase your production and provide high accuracy in accordance with your package filling specifications.
Typical distribution simulation for medical devices is defined in astm d4169 standard practice for performance testing of shipping containers and systems dc 13.
Testing intensity is determined based on the specific device and system.
Poor packaging can cause a host of problems for medical device companies and their customers.
Medical device packaging validation varies greatly depending on the risk policy of the medical device manufacturer as well as the class of medical device.
Flexible packaging machines for medical supplies.
Astm and ista series distribution testing offer a set of specific test methods for compliance with iso 11607.
Flexible packaging in the medical industry is a rapidly growing and changing market.
It s important that our customers understand all of our packaging machine functionality in terms of accuracy of the sealer machine alarms as well as other negative machines attributes.
Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.
