Blu - Biocompatibility Certification ISO 10993-10

Blu recently passed the ISO 10993-10 Skin Sensitivity certification for bio-compatibility. This means that Blu is now certified for making devices that touch human skin externally. This is certainly great news for many of our professional users. Here is the guideline to ensure proper use:

Blu

1. Clean in two batches of 95%+ Ethanol or IP. The first cleaning pass can be in a batch of Ethanol and IPA that could be dirty (was previously used) for about 3-5 minutes. The goal is to remove excessive resins. After the first batch finishes, move to 2nd cleaning batch with clean Ethanol or IPA for an ultrasonic bath of about 5 minutes.

Please follow safety instruction here for using alcohol in ultrasonic device.

2 After finishing cleaning in the 2nd batch, bake the print at 60C for 20 minutes to remove moisture and residuals.

3 After baking, please cure with a 405nm UV light fixture for 20 minutes.

Blu latest certification

Blu passed the ISO 10993-5 and ISO 10993-10 tests for in vitro cytotoxicity and skin sensitization, respectively. Click here to view Blu ISO-10993 - 10 and ISO - 10993 - 5 Certification

Blu

 

Certification

13 comments

Harry Leggett

Harry Leggett

is this still a carcinogenic resin?

Ines

Ines

Can resin blu Emerald Blue be autoclaved after the printed parts have been properly washed? If so, what are the autoclave conditions? Thank you!

Brent

Brent

Is Blu Obsidian Black the same as Blu Emerald Blue with a different pigment added?

Brent

Brent

I purchased a bottle of Blu Nylon Black. The label says ISO-10993. Is there any documentation to support that the Nylon Black version of Blu is ISO-10993 certified?

Siraya Tech

Siraya Tech

Hi, we understand your confusion, the basic formula of Blu is the same, Blu Clear V2 is the version of Blu without pigment.

Brent

Brent

Your reply says that “Blu’s biocompatibility certification applies to all resins in the Blu series”. How do you know this? Is there any documentation/certification that supports this statement?
The published certification is for the original Blu only.

Loren Abdulezer

Loren Abdulezer

Must the baking be at 60C or can it be equivalently accomplished at a lower temperature but but of course, for a longer duration?

Charles

Charles

Can you start adding “lot number” to the bottle? this is iso 10993 right? If there is a problem with the product (manufacturing batch). We need to be able to report it.

Joe Scotto

Joe Scotto

It seems that the certification is only for the Blue color of the Blu resin. The test results available here do not include for other colors: https://drive.google.com/drive/folders/1hpPQVyiM6ztF1Ckxe9APhRbLNzyflrJV

Could you elaborate on why this is? You say that all versions of Blu are certified but according to that, only the Blue color is.

Siraya Tech

Siraya Tech

Blu’s biocompatibility certification applies to all resins in the Blu series.

Evan Weber

Evan Weber

Will this work with BLUV2 as well?

sascha

sascha

Does this include past batches or only batches made after X date? Blue v2 as well or just original blu?

sascha

sascha

Does this include past batches or only batches made after X date? Blue v2 as well or just original blu?

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