ASTM E1053: Antiviral Claim Verification for Surface Microbicides
Airmid Healthgroup provides independent, GLP-compliant ASTM E1053 testing services — evaluating the virucidal efficacy of liquid, aerosol, foam, and trigger-spray microbicide products intended for use on inanimate, non-porous environmental surfaces. Our ISO/IEC 17025-accredited laboratory delivers the independently validated antiviral data needed for EPA and FDA regulatory submissions and third-party product claims.
The Standard for Virucidal Surface Disinfectant Validation in the US Market
ASTM E1053 is the primary ASTM standard used to assess the virucidal activity of products on hard, non-porous surfaces. It is widely referenced by the US EPA and FDA for antiviral product registration and claim substantiation — making it an essential test for manufacturers entering or expanding in the North American market.
Scope of ASTM E1053
ASTM E1053 is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger-spray microbicides intended for use on inanimate, non-porous environmental surfaces. The method may be employed with most viruses that can be grown in cultured cells, though other host systems — such as embryonic eggs — may be used with proper justification and documentation.
This test method may be used to determine the effectiveness of liquid, aerosol/foam, and trigger-spray products against designated prototype viruses. The number of lots of the test substance and the number of replicates in each test will depend on the requirements of the target regulatory agency.
Certain regulatory agencies may require additional testing using other carrier tests for product registration purposes.
Key Scope Requirements
Product Types Covered
Liquid disinfectants, aerosols, foams, and trigger-spray products intended for use on inanimate, non-porous environmental surfaces.
Virus Flexibility
The method can be employed with most viruses that can be grown in cultured cells — allowing testing against the specific viral targets most relevant to your product’s claims and intended market.
GLP Requirements
Testing must follow GLP regulations where applicable — 40 CFR Part 160 for EPA submissions and 21 CFR Part 58 for FDA submissions. Airmid conducts all ASTM E1053 testing in full GLP compliance.
Biosafety Requirements
This test method should only be performed by those trained in microbiological and virological techniques in facilities equipped for work with infectious agents at the appropriate biosafety level — as provided by Airmid’s BSL-2 virology laboratory.
ASTM E1053 Testing Protocol
Why Choose Airmid Healthgroup for ASTM E1053 Testing?
BSL-2 Virology Laboratory
Our purpose-built biosafety level 2 virology laboratory is equipped and staffed for safe handling of the infectious agents required for ASTM E1053 testing.
EPA & FDA GLP Compliance
All testing is conducted in accordance with 40 CFR Part 160 (EPA GLP) and 21 CFR Part 58 (FDA GLP) — producing data suitable for US regulatory submissions.
ISO/IEC 17025 Accredited
Our laboratory holds ISO/IEC 17025:2017 accreditation from the Irish National Accreditation Board (INAB, Reg. No. 284T) — ensuring results meet the highest international standards of accuracy and reproducibility.
Flexible Virus Selection
We work with manufacturers to select the most appropriate test viruses for their product’s intended claims and target regulatory agency — including Influenza A, Human coronavirus, RSV, and others.
Request a Quote for ASTM E1053 Testing
Contact Airmid Healthgroup to discuss your antiviral surface disinfectant testing requirements and receive a tailored quote for ASTM E1053 testing.
Frequently Asked Questions
What is ASTM E1053 used for?
ASTM E1053 is used to evaluate the virucidal efficacy of liquid, aerosol, foam, and trigger-spray disinfectant products on inanimate, non-porous surfaces. It is the primary ASTM standard for antiviral surface disinfectant claim substantiation and is widely accepted by the US EPA and FDA for product registration purposes.
Which viruses can be used in ASTM E1053 testing?
The method can be employed with most viruses that can be grown in cultured cells. Commonly tested viruses include Influenza A (H1N1 and H3N2), Human coronavirus, RSV, Adenovirus, and others. The specific virus strains used will depend on your product’s intended claims and the requirements of your target regulatory agency. Contact our team to discuss the most appropriate organisms for your product.
What is the difference between ASTM E1053 and BS EN 13610?
ASTM E1053 is a US standard primarily used for EPA and FDA submissions, testing virucidal efficacy of surface disinfectants using human-relevant viruses grown in cultured cells. BS EN 13610 is a European standard that uses bacteriophages as surrogate test organisms for food and industrial disinfectant applications. For products targeting both US and European markets, both tests may be required.
Is additional testing required alongside ASTM E1053 for product registration?
Certain regulatory agencies may require additional carrier tests alongside ASTM E1053 for product registration purposes. The exact requirements depends on the target regulatory agency, product type, and claims being made. Airmid’s team can advise on the full testing programme required for your specific regulatory submission.
What will I receive after ASTM E1053 testing?
You will receive a full GLP-compliant test report detailing the methodology, virus strains used, test conditions, virucidal efficacy data, and conclusions — ready for use in EPA submissions, FDA submissions, and marketing claims. The report will meet the GLP documentation requirements of 40 CFR Part 160 and/or 21 CFR Part 58 as applicable.
Related Tests and Services
- Virology Laboratory Services
- BS EN 13610:2002 — Virucidal Activity (European Standard)
- BS EN 1276:2019 — Bactericidal Activity
- BS EN 13697:2015 — Non-Porous Surface Bactericidal/Fungicidal Activity
- ISO 18184:2019 — Antiviral Activity of Textiles
- Microbiology Laboratory Services
- Claims Verification Services
- Customised Testing Projects
