Packaging Validation for Non-Sterile Package


Trusted Information Resource
Hi Guys,
Does anyone know to which standard you need to test a non-sterile package, like a PC box?

I could not find an harmonized standard for non-sterile packaging.



Trusted Information Resource
Thanks Ronen and Pads38,
I reached out to a friend outside the cove and summarized what I've learned:

1. It is required in the EU; See MDD, Annex I, section 8.6:
"Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilization indicated by the manufacturer."

2. It is also required by QSR. See 21 CFR 820.130:
"Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution."
3. In the US there is a consensus standard for it - ASTM D4169.
4. It gets interesting when you look at the MDD list of harmonized standards. There is no harmonized standard for non-sterile packaging. But ISO 11607-1: Packaging for terminally sterilized medical devices, which is a harmonized standard, references the ASTM D4169.
5. My colleague tells me that the notified body will accept packaging validation based ASTM D4169.
6. Another interesting side story - if the packaging is for telecom equipment, there is a free shipping standard for it from ETSI (European Telecommunications Standard Institute); I believe It's ETSI EN 300 019.
7. There are a bunch of other environmental standards that can be used to show compliance to the regulation. Armed with this knowledge you just need to go to a testing lab and see what type of test they can offer.

Learn and be wise!


Trusted Information Resource
(broken link removed)
Qualification of Packaging and Validation of Shipping/Transport Procedures
(American Association of Tissue Banks (AATB))

Environmental Engineering (EE); Environmental conditions and environmental tests for telecommunications equipment; Part 2-4: Specification of environmental tests; Stationary use at non-weatherprotected locations

Packaging Process Validation

Recognized Consensus Standards

Recognized Consensus Standards

Gert Andersen

I'm working on a project which is a Class 1 Custom Made Device.
Thanks for guiding me in the right direction, which lead me to this alternative:
ASTM D7386 - 16
Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems


Now with implementation of MDR, I guess there is also no change compared to MDD -> No additional requirements for non-sterile packaging compared what we know. Was by someone this ASTM D7386-16 Standard sucesfully appled (as an alternative)?

Kind Regards
Top Bottom