Let’s Talk VOCs: Ensuring Medical Device Safety with ISO 18562

What’s in the air your device is giving off? When it comes to medical devices, even invisible emissions like volatile organic compounds (VOCs) can pose very real risks. In this episode, we break down ISO 18562, the standard guiding the evaluation of gas pathway emissions in medical devices, and how it plays a vital role in protecting patient health. Whether you're developing ventilators, anesthesia systems, or breathing circuits, tune in to learn how to ensure compliance, minimize emissions, and safeguard users from the inside out.

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Transcript

Let’s Talk VOCs: Ensuring Medical Device Safety with ISO 18562

 00:17 --> 00:22
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Hey friends, and welcome to another episode of Assurance in Action. I’m Taylor…

00:22 --> 00:34
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

...and I’m Ashli. Today we’re exploring the sometimes-overlooked, always-important world of VOC testing in medical devices, specifically within the ISO 18562 framework.

00:34 --> 00:45
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

We’re walking through key takeaways from the webinar presented by our friends and colleagues Jesse and Brooke from Intertek, two pros who broke it all down from both a testing and toxicology standpoint.

00:45 --> 01:11
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

We’re going to unpack the webinar, add some real-world context, and highlight practical insights that you can apply today. Then, we’ll nudge you back to the full session for the nitty gritty science-y stuff.

Let’s start with the basics. VOCs, or Volatile Organic Compounds, are organic substances that can vaporize and enter the air we breathe. For devices that deliver air or oxygen to patients, this matters a lot.

01:11 --> 01:29
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

And the standard now actually uses the broader term "VOSs", which is Volatile Organic Substances. These include VVOCs, VOCs, and SVOCs, basically, a whole soup of possible emissions based on boiling point ranges.

01:29 --> 01:44
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

One point they made that stuck with me: Not all VOCs are dangerous. They're everywhere, even your essential oils and furniture off-gas VOCs, but in medical devices, we care about patient exposure in vulnerable moments.

01:44 --> 02:00
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Right, like newborns in incubators or patients with respiratory illnesses. These are sensitive users. The whole goal of ISO 18562 is to evaluate the biocompatibility of devices that are literally delivering life-sustaining air.

02:00 --> 02:14
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Let’s list out some of the affected devices. We’re talking ventilators, oxygen concentrators, nebulizers, anesthesia workstations, CPAP machines… even accessories like hoses and masks.

02:14 --> 02:25
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Basically, anything that air travels through before entering the body. So, even tubing and cannulas are subject to VOC evaluation under ISO 18562.

02:25 --> 02:35
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Which means, manufacturers need to be thinking about materials, adhesives, curing methods… and how aging or sterilization might impact VOC emissions.

02:35 --> 02:49
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Jesse and Brooke did a great job showing how VOC testing isn’t just about running a sample through a machine. You need to think about device-specific conditions, like airflow rate, use duration, air source, and device cycling.

02:49 --> 03:00
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And the testing environments are carefully controlled, temperature and humidity matter, and air sources like compressed vs. ambient air change results.

03:00 --> 03:09
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

They even create custom-built chambers to test devices under realistic use conditions. That level of preciseness really blew me away.

03:09 --> 03:25
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Me too. And they use smart tech like thermal desorption tubes and DNPH cartridges for collecting all the volatiles, VVOCs to SVOCs. Then the samples go through TD-GCMS and HPLC analysis.

03:25 --> 03:33
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

What’s wild is how concentrated those samples are like 100,000x before analysis. It’s science magic.

03:33 --> 03:49
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Here’s where it gets really practical: Brooke pointed out that R&D testing, before final production, can save so many headaches. You can test variations, materials, and even aging simulations to catch issues early.

03:49 --> 04:01
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

We’ve seen clients try to "pass" VOC testing last-minute, only to find their adhesives are causing formaldehyde emissions. Pre-screening lets you fix that without wasting product or delaying market entry.

04:01 --> 04:10
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Now the fun part is what happens after the lab hands you a VOC emissions report. You don’t just look at the numbers, you have to assess the risk.

04:10 --> 04:20
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

The toxicological team uses that data to estimate patient exposure, compare it against established inhalation limits, and figure out if it’s safe.

04:20 --> 04:33
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And if there’s no clear limit available? That’s where ISO 10993-17 comes in. It helps derive a Tolerable Intake (TI) using conservative safety factors.

04:33 --> 04:49
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

They calculate worst-case Estimated Exposure Dose (EED), then compare it to the TI to get a Margin of Safety. If Margin of safety is ≥ 1, you’re good. If it’s <1? More action needed.

04:49 --> 04:59
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

They even walked us through a benzene case study that showed how a compound can be detected, but still be within safe limits when you run the numbers.

04:59 --> 05:11
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Let’s geek out a little. I loved the part where they explained how DNPH cartridges work for aldehydes. It reacts with carbonyls to form stable hydrazones, like mini molecular ID tags.

05:11 --> 05:21
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And then TD-GCMS for VOCs, it’s basically like catching and concentrating ghosts, then fingerprinting them. Super sensitive, super detailed.

05:21 --> 05:33
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

And the limits for reporting are tight; 2 µg/m³ for general VOCs, and even 1 µg/m³ for pre-identified targets.

05:33 --> 05:43
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

We hear this a lot: “VOC testing sounds intimidating.” But it’s really about understanding risk, being proactive, and using the science to keep patients safe.

05:43 --> 05:51
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Exactly. The team isn’t there to say “gotcha”; they’re partners in getting your device to market safely and confidently.

05:51 --> 05:57
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Plus, the evolving ISO framework gives you tools, not roadblocks. It’s about structure, not restriction.

05:57 --> 06:04
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Okay, Ashli, rapid fire: Can a single CPAP mask cause a VOC compliance failure?

06:04 --> 06:11
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Yes—especially if there’s off-gassing from foam or adhesives. But that’s why material screening exists!

06:11 --> 06:19
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

ok, so probably the most popular questions we get: how long does ISO 18562 testing take?

06:19 --> 06:27
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Typically 4–6 weeks, but it depends on test chamber design, material pre-conditioning, and number of samples.

06:27 --> 06:29
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Should startups care about this?

06:29 --> 06:35
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Absolutely. If your device moves air to a patient, then you’re in the game.

06:35 --> 06:49
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

So that wraps our tour of ISO 18562 and VOC testing. A big shoutout to Jesse and Brooke for the incredible webinar, go check it out if you want to see the full workflows, standards, and technical examples.

06:49 --> 07:00
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And remember: compliance isn’t just a checkbox, it’s a lifestyle. So if you’re developing a new product, or refreshing an existing one, start asking these questions now. The earlier, the better.

07:00 --> 07:05
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Like flossing. You don’t have to do it every day… but you really, really should.

07:05 --> 07:13
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Thanks for tuning in to Assurance in Action. We’ve tested the air, screened the foam, and yes, still no VOCs in our vibes.

07:13 --> 07:22
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Until next time, may your devices be clean, your standards be met, and your test chambers smell like victory.

07:22 --> 07:26
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Stay compliant, stay curious, and stay safe… 

07:26 --> 07:28
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

and maybe don’t sniff the mask. 

07:28 --> 07:31
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Bye guys!