ISO 15714:2019 Testing — Frequently Asked Questions
ISO 15714:2019 is one of the most important international standards for evaluating the effectiveness of air treatment devices against airborne microorganisms. Below, the Airmid Healthgroup expert team answers the most frequently asked questions about the standard — and how we can help you apply it to your product testing.
Answered by Dr. Anna O’Donovan · Airmid Healthgroup
What is ISO 15714:2019?
ISO 15714:2019 is an international standard that describes a controlled laboratory method for evaluating the antimicrobial performance of air treatment devices using aerosolised biological agents — including bacteria and viruses.
What types of devices does ISO 15714 apply to?
This standard is relevant for any product claiming to reduce airborne microorganisms, including:
- → Air purifiers
- → HVAC-integrated filtration systems
- → UV-C and photocatalytic units
- → Electrostatic precipitators
- → Plasma-based air cleaners
- → Hospital-grade infection control systems
Why is this testing important?
Testing to ISO 15714:2019 provides quantitative evidence that your device works under controlled, reproducible conditions. It supports:
- → Product development and performance benchmarking
- → Regulatory submissions (FDA, CE, Health Canada)
- → Marketing claims for microbial reduction
- → Customer and stakeholder confidence
What microorganisms are used in ISO 15714 testing?
Common test organisms include:
- → Serratia marcescens — a safe bacterial surrogate
- → MS2 bacteriophage — a viral surrogate
- → Other surrogates may be selected depending on intended use and jurisdiction
What does the test involve?
- A controlled test chamber is filled with a known concentration of aerosolised microorganisms.
- The air treatment device is operated under defined conditions.
- Air samples are collected over time and cultured to determine viable microorganism counts.
- The log reduction of microorganisms is calculated and compared to a control (non-treated airflow).
How is ISO 15714 different from other standards?
Unlike standards that test surface decontamination or air filter efficiency, ISO 15714 focuses on real-time airborne microorganism reduction. It is considered one of the most rigorous aerosol-based efficacy standards for air disinfection devices — making it the preferred choice for manufacturers seeking to substantiate performance claims with credible, regulatorily-recognised data.
Does ISO 15714 meet FDA or CE requirements?
While ISO 15714 is not a regulatory requirement in itself, it is widely recognised by regulators as part of the scientific evidence package for efficacy. It can support submissions under:
- → FDA 510(k)
- → EU MDR
- → Health Canada filings
- → EPA device registration (in conjunction with other tests)
Can the standard be adapted to my specific product?
Yes. At Airmid Healthgroup, we routinely adapt ISO 15714 protocols to better reflect the airflow characteristics, intended use, or real-world application scenarios of our clients’ technologies — while maintaining scientific and regulatory integrity throughout.
Why choose Airmid Healthgroup for ISO 15714 testing?
- → Purpose-built bioaerosol testing chambers
- → Access to a range of surrogates and test protocols
- → GLP-level quality systems
- → Trusted by top-tier medtech and air purification companies
- → Scientific team with deep expertise in indoor air microbiology
How long does testing take?
Typical ISO 15714 studies can be completed within 4–8 weeks, depending on device complexity, test organism selection, and regulatory data requirements.
How do I get started?
Contact our team and we’ll guide you through:
- → Protocol development
- → Selection of appropriate test organisms
- → Scheduling and sample logistics
- → Regulatory support, if needed
Airmid Healthgroup · ISO 15714:2019
Still have questions about ISO 15714?
We’re happy to walk you through how this standard applies to your product. Contact us for a consultation or to request a sample test report.
Related services
- Custom Bioaerosol Protocols for Air Disinfection Devices
[FIX NEEDED: confirm URL is correct]
Related articles
Author
Dr. Anna O’Donovan
Physician, Dentist & Medical Science Writer · Airmid Healthgroup
Dr. Anna O’Donovan qualified in Medicine from Trinity College Dublin (1997) and subsequently in Dentistry (2001), spending five years in General Practice and fifteen years in Dentistry before pivoting to science communication. For five years she worked with Allergy Standards Ltd as a medical and lifestyle author, translating complex scientific research into evidence-based content. At Airmid Healthgroup she focuses on the impact of indoor air quality on respiratory health, allergies, and overall wellbeing — bridging scientific research and accessible communication for industry and consumer audiences. She is an award-winning author, including a prize winner in the Baileys First Chapter Women’s Prize for Fiction.
