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Standard for Packing and Transport of Sterilized Medical Devices

jiligan

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#1
I am looking for a standard for the packing configuration of medical devices that would state how the product is to be packed in shipping cartons to be transported to the sterilization facility and back or how the sterilized medical device is shipped to the end user. Is it stated in a standard that the product should not be permitted to move around inside the shipping container or that voids should be filled to prevent damage to the packaging of the product during transportation? :thanks:
 
#2
jiligan,

the governing standard is ISO 11607-1:2006. However, this standard is not prescribing specific packaging configurations, including the protective packaging, refer to section 3.13 ibid.:

protective packaging configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use
As long as you fulfill this requirement you are free in tailoring your packaging configuration to your specific needs, including for the purpose of terminal sterilization and distribution to the market, respectively.

HTH,

Gerhard
 
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