Does ISO 10993 Apply to Packaging? (e.g. Travel Case)

[Mark Meer]

Curious if ISO 10993 might apply to travel cases for portable medical equipment intended for home use.

Take hearing-aids, for example: they come with a small travel case.

Technically, the "patient" in this case is the one interacting with the case, and so there is a degree of patient contact with the case.

So, strictly by the standard, it seems that you'd need to consider biocompatibility.

However, on a practical level, it seems this is unreasonably burdensome to the manufacturer. The travel case really has nothing to do with the medical application of the device, and the nature of the way the "patient" interacts with it is really no different from any other every-day commercial case (e.g. your wallet, sun-glasses case, mobile-phone case...etc.).

What do you think?

 

[Sam Lazzara]

Hi Mark,

Interesting question. If the odds are very low that toxic substances will leach from the travel case into the device, and therefore be transmitted to the patient, and if these low odds are documented in a justification, I don't expect regulators would be too disturbed.

Most of my experience with packaging that directly contacts a medical device is sterile-barrier packaging. In this case, we evaluate/test the device after it is terminally sterilized while in contact with the device, so we are therefore evaluating the potential impact the packaging may have on the device.

In FDA's 2016 biocompatibility guidance (attached), I found this definition:
Final finished form - term used for a device or device component that includes all manufacturing processes for the “to be marketed” device including packaging and sterilization, if applicable

The only other appearance in that guidance for the term "package" or "packaging" is this:
When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate.

I realize the your "travel case" is probably not also used as the finished device packaging but if it was, that could solve your dilemma - since evaluation/testing should be performed on finished, packaged devices in "final finished form".

 

[Ronen E]

Strictly speaking, use-level packaging (ie excluding shipping / logistic / wholesale packaging) should be biologically evaluated. Not necessarily tested in any specific way. The standard provides for analysis and evaluation of the risk, and in my understanding if the risk is deemed sufficiently low it can be left at a documented review. Yes, in your example the designer would need to pay attention and select transient-intact-skin-contact-benign materials, however actual testing (cyto etc.) could probably be justified away.

 

[Remus]

There is a standard for packaging ASTM F2475.

According to that standard for your product its not needed.

 

[Sam Lazzara]

Good find, Remus. That standard seems to focus on sterile barrier packaging, even though the title is broad - Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials.

It implies that, for the packaging supplier, cytotoxicity testing is probably the only "test" you would need to perform. Of course, the finished device manufacturer is more than a packaging supplier.

Info below is directly from ASTM website for ASTM F2475

Significance and Use

The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical or biological properties of the device. This evaluation may include both a study of relevant experience with and actual testing of packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.

The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.

1. Scope

1.1 This guide provides information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems used to contain a medical device.

1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.