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Packaging standards - ASTM vs ISTA

marie luis murray

Starting to get Involved
#1
Dear readers,

we are dealing with a medical device that is packaged using hdpe bottles and Threaded closure. These bottles are placed inside a box (2ary packaging) and then three of these secondary packaging boxes are placed in a bigger box (3ary packaging).

We are willing to cerity the medical device under the MDR in europe. The product will be shipped from south america to europe

We are delineating which of the packaging guidelines apply and which differences, pros and cons are between them:

- ASTM D4169: accepted by regulators under MDR?
- ISTA 2A
- ISTA 3

thanks a mlot for your help!

MLM
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
marie,

as long as your chosen test method covers your mode of transportation and packaged-product configuration, you can chose your preferred one. Typical test methods are listed in ISO 11607-1:2019, Annex B.

Hope this helps,
 
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