ISO 10993 vs. ISO 18562: Which Biocompatibility Standard Applies to Your Device?

Introduction

Choosing the right biocompatibility standard is critical for regulatory success. ISO 10993 and ISO 18562 both assess medical device safety. But they apply to different risk pathways. Understanding their scope helps manufacturers design compliant devices, satisfy regulators, and protect patients. 

What is ISO 10993 and Why is it the Foundation of Biocompatibility Testing?

When it comes to biocompatibility, the umbrella standard ISO 10993 has been the pillar of medical device evaluation. It covers a wide range of endpoints: irritation, cytotoxicity, sensitisation, systemic toxicity, and more. However, a critical ‘blind spot’ in ISO 10993 is inhalation risk.

Why was ISO 18562 Introduced for Respiratory Medical Devices?

ISO 18562 was introduced to address the risks of inhalation from medical devices delivering breathing gases. Since 2017, regulatory bodies including the FDA, EU MDR, and Health Canada have recognised ISO 18562 as a critical requirement for biocompatibility submissions for respiratory-related medical devices.

What is the Difference Between ISO 10993 and ISO 18562?

The key difference: ISO 10993 focuses on the effects of material contacting tissue (read more about the most universal ISO 10993 testing here), whereas ISO 18562 assesses the risks from the exposure-pathway. 

The ISO 18562, similar to the ISO 10993, begins with a biological risk evaluation prior to testing (ISO 18562-1). Importantly, the standard does not prescribe fixed pass/fail limits. Instead, manufacturers must demonstrate that emissions are as low as reasonably practicable and within safe exposure levels for the intended patient population (e.g. infants, adults, or long-term ventilated patients). 

What are the Four Parts of ISO 18562 Testing?

The subsequent parts of the standard outline specific tests: 

ISO 18562-2: Particulate Emissions 

The first test (ISO 18562-2) focuses on particulate emissions. So, this could be particles from tubing, filters or valves of a medical device which deliver gases. The test measures the number and size distribution of the airborne particles (usually that are 0.3μm, since those can deposit deep in the lung) that are unintentionally emitted into the gas stream over a long exposure. 

ISO 18562-3: Volatile Organic Compounds (VOCs) 

The second test detailed (ISO 18562-3) is specific to volatile organic compounds (VOCs). These can be by-products/off gassed from materials such as plastics, adhesives or lubricants. VOCs are collected from the gas stream and analysed using thermal desorption–gas chromatography–mass spectrometry (TD-GC-MS). 

ISO 18562-4: Leachables in Condensates 

The third test (ISO 18562-4) identifies leachables in condensates. In humidified circuits within medical devices, condensation can form. The mix of condensed water and materials of medical devices can cause chemicals to be extracted from materials which can be inhaled by patients as aerosolised droplets. Testing involves collecting condensates under simulated use conditions, then analysing for extractables/leachables (e.g. inductively coupled plasma mass spectrophotometry). 

How do You Know Which Biocompatibility Standard Applies to Your Device?

Ultimately, ISO 10993 and ISO 18562 are complementary rather than competing. Understanding when to apply each standard is essential for demonstrating a robust biocompatibility technical file, satisfying regulators, and protecting patients. 

So which standard applies to your medical device? 

• If your device involves skin, blood, or tissue contact, ISO 10993 is essential. 
• If your device delivers breathing gases, ISO 18562 is required. 
• In some cases (like ventilators with external components) you may need to comply with both. 

Why Understanding Both Standards is Key to Regulatory Success

ISO 10993 ensures biological safety for tissue-contacting materials, while ISO 18562 ensures inhalation safety for respiratory devices. Together, they provide a complete framework for medical device biocompatibility testing and compliance under global regulations.