Medical Device Class 2A, non sterile bodyworn packaging requirements

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Ashwath

Greetings everyone!!

Well I am basically new to this medical packaging field, it would be great if you all could enlighten me your with your valuable insights.

We are planning to deploy a class 2A, non sterile body worn device, which adheres to IEC 60601. For the same we are looking for packaging & Storage requirements.

But unfortunately, I could not find any requirements for non sterile packaging apart from labelling , Curious to know if I am missing anything??

Regards,
Ashwath
 

Mark Meer

Trusted Information Resource
Hi Ashwath, and welcome to the forum!

The manufacturer (or specification developer) should have defined any packaging, handling & storage requirements as part of the design process, based on a risk assessment and intended use.

Somewhere, an evaluation of the risk from improper packaging, storage, and handling should be documented. This, combined with the intended use & user needs, are used to define appropriate design requirements.

Maybe it is the case that the product in question is completely unaffected by environment, and anticipated transport/storage conditions. ...in which case there may be no particular requirements.

If you need to define general conditions, you might just have them match those in Annex A (General Guidance and Rationale) of EN 60601-1 (see A.4. Rationale for Particular Clauses and Sub-Clauses, sub-clause 7.9.3.1). ...this assumes, of course, that these conditions don't conflict with existing design requirements / risk controls / intended use.
 
A

Ashwath

Thanks Mark for the quick inputs!! much appreciated.

Additional Quires :
1) So basically as per my understanding, we can design our custom packaging box with generic materials (Cardboard box+foam) which in turn adheres to our own set requirements considering all the risk involved & intended use cases, Correct?

2) Also curious to know if "International Safe Transit Association", (ISTA Standard 2A -Partial Simulation Performance Tests, are applicable for our packaging ?

Regards,
Ashwath
 

Mark Meer

Trusted Information Resource
1) So basically as per my understanding, we can design our custom packaging box with generic materials (Cardboard box+foam) which in turn adheres to our own set requirements considering all the risk involved & intended use cases, Correct?

That is correct. Ensure you documented somewhere (e.g. risk management activities) consideration of the potential effects of improper transport and storage, and then followed commensurate design controls.

If there is very low risk, packaging in a off-the-shelf envelope may be sufficient. If you have something sterile, or fragile, you'd want to verify that the anticipated transport & storage conditions do not affect these properties.

2) Also curious to know if "International Safe Transit Association", (ISTA Standard 2A -Partial Simulation Performance Tests, are applicable for our packaging?

It, like all standards, is intended to be voluntary. It is a tool to help you gather evidence of package integrity. ISTA have just systematized a process for checking to what degree packaged items are affected by drops, impact, vibration, and other anticipated shipping stress. ..but whether this system or the data they'd give you is beneficial to you, is your decision. The ISTA system can be helpful if you are concerned that your product may be affected by these things, and would like to check.

We had a customer who wanted these tests. They recognised their product is fragile, and so decided to make a design requirement that the device is unaffected following ISTA 2A tests. This was their decision. They picked ISTA tests because the tests meet their requirements to evidence that their product is packaged properly. Had they only been concerned about the product breaking because of dropping, they may have opted for an in-house drop-test only.... Whatever meets your requirements...
 
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Ashwath

Thanks Mark for your time & valuable inputs!! ,Will definitely consider the same.
 

yodon

Leader
Super Moderator
I don't know how widespread this is or if other carriers offer it but FedEx will do a series of packaging durability tests - I believe based on the ISTA tests - basically for the price of shipping. That will give you an excellent idea of how well your packaging protects your product and you get a nice test report that can support your assertion that the product is adequately protected during shipping.
 

Mark Meer

Trusted Information Resource
...FedEx will do a series of packaging durability tests - I believe based on the ISTA tests - basically for the price of shipping.

"...basically for the price of shipping."?? Seriously?
If so, I'll definitely have to look into it next time we have such needs...

If I recall correctly, our ISTA tests cost ~$750-1000, but included environmental conditioning, several drop and vibration tests, and of course the written report itself. It's great if FedEx is offering a comparable competitive service! ...I'm just amazed they could make it profitable if, indeed, they only charge a fraction of the cost.
 
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