Formlabs announced a new material certification, and it’s more important than you might think.
The news from Formlabs involves one of their 3D printer resins, Tough 1500 Resin. This is a semi-rigid material that has notable durability. It could be used for production end-use parts, as well as prototypes, and is gray in color.
Formlabs announced that this material has achieved ISO 10993-1, which means it is certified for skin contact safety. Specifically, it has passed these ISO standards:
- ISO 10993-5: Not cytotoxic
- ISO 10993-10: Not an irritant
- ISO 10993-10: Not a sensitizer
This opens up the possibility for operators to 3D print wearable items with Tough 1500 Resin.
Hold on, haven’t wearable 3D prints been around for a while?
Yes, they have. But there’s a big difference here. While it’s long been possible for anyone to design a wearable object, 3D print it and wear it, there are risks.
What happens over time when that chunk of ABS from unknown sources presses against your skin for several days? Are there chemicals in the resin that might be gradually absorbed? What happens when you eventually get a toxic reaction after repeated exposures?
There’s nothing stopping individuals from doing so; it’s their own problem if something bad happens. However, (honorable) companies will not 3D print wearable objects without legal certainty there will be no issues.
Large companies in particular would be resistant to taking that risk simply due to the possibility of an expensive lawsuit. While people often complain about lawyers and lawsuits, this is a case where they actually protect the individual. That legal threat generally prevents companies from doing bad things with incorrect materials.
But what if there were no legal risk?
That’s the purpose of the certification. The certification means a company manufacturing a product with Tough 1500 Resin can say with absolute certainty that a recognized authority has declared that this product is safe for skin contact within the specified parameters of the ISO standard.
This makes the company immune to that type of lawsuit and opens up the possibility of manufacturing.
This is the goal of Formlabs in this case: remove a barrier to extensive machine use by customers. Now it’s only a matter of time before some ingenious Formlabs customers create an innovative 3D printable design for a wearable and produce it using Formlabs equipment.
Even better for Formlabs is that such manufacturing operations might represent not one machine sale, but perhaps hundreds to establish a factory to produce hundreds or thousands of parts per day. Sales of that type are quite efficient: one sales workflow to capture hundreds of units.
As you can see, a certification like this can be extremely powerful. It’s not just good for Formlabs, but also good for manufacturing buyers, who can produce unique parts for new applications.
The more certifications for 3D printing we see, the better.