FDA Packaging Test Requirements - Product is PE Bag

[Job.hong]

for FDA packing test.the product is PE bag.
Does these test should do necessary?
1. Seal Strength ASTM F88;
2. Burst Strength ASTM F1140;
3. Thickness Variations ASTM F2251;
4. Tear Resistance ASTM D1004;
5. Dye Penetration ASTM F1929;
6. Seal Integrity ASTM F1886;
7. Microbial Barrier ASTM F1608

 

[bio_subbu]

Re: For packing test

Per FDA regulation Section 820.130 Device packaging tests are must to protect the device from alteration or damage during the customery conditions of processing, storage, handling, and distribution, but the testing requirements may vary depend on your product intended use. For further details refer standard ISO 11607 (Packaging for terminally sterilized medical Devices), it is also recommended to use as a guideline even in case of non-sterile devices. Or contact packaging testing laboratories.

Thanks and Regards
S. Subramaniam

 

[WilliamS]

It was not clear to me if the product itself was sterile or non-sterile.

 

[MIREGMGR]

Is the product a medical device that happens to be a PE-film bag of some sort?

Or is the product a pre-formed PE bag used for packaging medical devices?

The regulatory contexts of a medical device, and a packaging product for medical devices, are very different.

If it's a packaging product that will be used in sterile barrier packaging (i.e. for gamma sterilization), at least tests 1 and 6 will have to be performed by your customers, though you might want to run them prior to marketing to assure that they in fact are able to be passed.