I have a a question on biocompatiblity testing for silicone tubing, as follows:

Our supplier of silicone tubing can declare that all the materials from which he makes the tubing have been tested for biocompatiblity according to ISO 10993-1. He says that once the materials (from which the final tubing is made) are OK for biocompatiblity, then there is no need to test the manufactured tubing (end product).

Is this correct? Is there a difference between FDA and CE requirements in this regard?

Thanks.

Asherlee.

I think you need to define what the tube is used for and what type of testing was carried out. Without knowing your application it is difficult to be more detailed

Microbe

I have a a question on biocompatiblity testing for silicpone tubing, as follows:

Our supplier of silicone tubing can declare that all the materials from which he makes the tubing have been tested for biocompatiblity according to ISO 10993-1. He says that once the materials (from which the final tubing is made) are OK for biocompatiblity, then there is no need to test the manufactured tubing (end product).

Is this correct? Is there a difference between FDA and CE requirements in this regard?

Thanks.

Asherlee.I don't believe that to be a correct statement in general. You have to consider the intended use of your device. Look at the FDA Blue Book Memo G95-1 (http://www.fda.gov/cdrh/g951.html).

You may also want to consider if the testing the supplier did was based on tubing that was processed equivalent to yours. For example, if you will be gamma sterilizing the tubing, we would irradiate the samples before biocompatibility testing.

Generally both ISO 10993-1 and FDA's G95-1 (blue book) are used for biocompatibility testing

Thanks to all the people who replied - much appreciated.

The silicone tubing is intended for use in an infusion pump.
The tubing should comply with the following test requirements for biocompatibility evaluation and testing as set out in ISO 10993-1 (2003) for “an external communicating device in indirect contact with the blood path for <24 hours”:
• Cytotoxicity (ISO 10993-5).
• Sensitization (ISO 10993-10).
• Irritation or intracutaneous reactivity (ISO 10993-10).
• Systematic toxicity (acute) (ISO 10993-11).
• Hemocompatibilty (ISO 10993-4).
• USP Class IV (at least).

As the Administration Sets will be non-pyrogenic, the silicone tubing should also comply with the USP (United States Pharmacopeia) pyrogen testing requirements.

Sterilization of the Sets will be via Ethylene Oxide (EO) with the devices placed in a fixed chamber.

Regards,

Asherlee