Q&A: New Standard For Device Irritation Nudges Industry Away From Animal Testing – And Toward Tests On Lab-Made Human Skin
An ISO-recognized expert tells Medtech Insight why international standard ISO 10993-23:2021 urges irritation testing on laboratory-grown skin – also known as in vitro reconstructed human epidermis (RhE) – and why device makers will like it.
A new standard on medical device irritation from the International Organization for Standardization (ISO) is nudging manufacturers away from testing on animals.
Published by ISO in January, ISO 10993-23:2021 urges irritation testing on laboratory-grown skin – or in vitro reconstructed human epidermis (RhE) – instead. The standard includes an RhE test model that can replace old-school animal tests that have been used for decades, such as the Draize Test.
Device makers “are ready for new science. Some of these tests have been around since the 1950s and 1960s. It’s pretty ridiculous that we still rely on them,” said Thor Rollins, director of toxicology at Nelson Laboratories.
Rollins also is a member of ISO Technical Committee 194, the group that oversees the ISO 10993 set of standards, “Biological Evaluation of Medical Devices.” That series gives manufacturers tools to assess device biocompatibility and manage any associated risks.
ISO 10993-23 marks the first time irritation has been separated from sensitization in the series. Before it had its own standard, irritation was included in Part 10 of the set, “Tests for Irritation and Skin Sensitization.” ISO 10993-10 was first published in 1995, and updated in 2002 and 2010. (Part 10 is currently undergoing a revision to strip out irritation.)
“A lot of standards are currently being worked on, revised and reevaluated, so buckle up.” – Thor Rollins
“Lumping irritation and sensitization together into one standard made sense way back when, even though they’re two different test methods and two different biological reactions,” Rollins said.
“But five years ago, there was some new science that came out that took the emphasis away from animal testing and moved into in vitro alternatives, using RhE tissue,” he said. RhE tissue is “stem cells that are differentiated into skin. So they’re little human skins that we buy on a plate – they’re kind of cool.”
“So ISO 10993-23 isn’t just separating out sensitization and irritation, it’s also putting in this in vitro alternative,” Rollins said. “It’s not completely removing the animal test, but for Europe and Japan, once this standard is accepted, they’re going to rely on the in vitro test above the animal test. And that’s great – the idea is to get away from the animal tests.”
In an interview with Medtech Insight, Rollins added more context.
The standard is impactful because, one, we’re not testing on animals, and two, these tests are cheaper and quicker than the animal tests. So yeah, medical device manufacturers love the idea of going toward it, as long as the regulatory bodies accept it.
Rather, it’s the sensitization [under ISO 10993-10], which we’re working on now, that would save them a lot. So for an in vitro sensitization test, they’d go from $12,000 to $13,000, down to $1,500 or $2,000, and eight to nine weeks down to three to four weeks.
Right now if you look up -10, it’s still for sensitization and irritation. So we have a little contradiction going on where we have a standard just for irritation, and another standard with both sensitization and irritation. We’re working on that right now. We’re expected to have that out by the end of the year to update -10 to be just for sensitization so we can have two distinct standards.