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ISO 21702 Test
Measurement of Antiviral Activity on Plastics and
other Non-Porous Surfaces
This International Standard (ISO 21702 : 2019) is a proper method for measuring antiviral activity on plastics and other non-porous surfaces of antiviral-treated products against viruses.
ISO 21702:2019 test method is an important standard for assessing the effectiveness of non-porous products treated with antiviral agents, particularly those used in environments where viral contamination poses a significant risk to public health. As the demand for antiviral-treated products continues to rise, this standard provides manufacturers and product developers with a standardized means of confirming the validity of their materials.
The standard gives a robust framework by which the antiviral properties of plastic and other non-porous surfaces can be assessed. This test method is applicable to a wide range of antiviral-treated products, particularly used in healthcare and public spaces where the spread of viral infections must be minimized.
Products that can be tested with ISO 21702
A variety of plastic and non-porous surfaces can be tested using this standard. These include but are not limited to:
- Plastic surfaces: Commonly used in medical devices, PPE, and consumer goods.
- Non-porous materials: Non-porous surfaces such as rubber, ceramics, and coated metals
- Consumer goods: Surfaces that are most often touched, like mobile phones, keyboards and counters.
- Healthcare products: These include surgical instruments, bed rails, and other equipment that must be sterile and free from viral contaminants.
- Building construction materials: Building materials such as coatings for walls or floorings.
Sample preparation
For the ISO test, a total of 21 sterilized test specimens are required, divided into treated and control samples. The sizes for the treated specimens and the control should be (50 ± 2) mm x (50 ± 2) mm.
Treated samples
Nine sterilized treated specimens are needed for the evaluation of antiviral activity.
- Three treated samples are used to estimate the infectious titer of the virus after a 24-hour contact period. This measures how effective the surface is in reducing the viral load.
- Six treated samples are maintained as controls to test the suppressive efficiency of the test material toward the host cells. The control samples ensure that there is no cytotoxic effect on the host cells, no reduction in the cell’s sensitivity to the virus, and any antiviral activity present in the neutralizing broth should be effectively inactivated.
Control samples
Twelve sterilized untreated control samples will be required to provide a baseline for comparison.
- Three untreated control samples are used to measure the infectious titer of the virus immediately post-inoculation. This provides a reference of the viral activity before contact with the treated surface.
- After having a 24-hour contact period, three untreated control samples are tested to assess the amount of virus that remains viable on an untreated surface.
- In addition, six untreated control samples are used to verify the suppressive efficiency of the antiviral-treated samples. Like treated samples, these controls test for the absence of cytotoxic effect, maintenance of cell sensitivity, and neutralization of antiviral activity.
ISO 21702 test conditions
Temperature: The samples are incubated at a temperature of 25 ℃
Relative humidity: Relative humidity is maintained at 90%
Contact time: As per manufacturer’s instructions. Typically 24 hrs.
ISO 21702 test requirements
- The test viruses include a relatively susceptible Influenza A and Feline Calicivirus. At MIS, we also run the test by using the following viruses: SARS CoV-2, Beta Coronavirus (OC-43) (ATCC VR-1558), Human Coronavirus (229E) (ATCC VR-740), Influenza A (H1N1) (ATCC VR-1469), Influenza A (H3N2) (ATCC VR-1679), Adenovirus, Norovirus, Poliovirus, Vaccinia Virus.
- All the samples have to be assayed at an appropriate concentration of the virus, known as a virus titre, in order to maintain consistency in testing.
ISO 21702 test methodology
The test follows a systematic and controlled procedure for determining the antiviral activity of the treated materials. Here is a step-by-step explanation of methodology:
- Preparation of samples
Specimens are prepared as per the standard’s guidelines. Treated and untreated samples are kept separately in a sterile plate to avoid cross-contamination.
- Application of test inoculum
A known volume of 400 µL of viral inoculum is spread over the surface of each sample. A coverslip is gently placed on the inoculum and pressed lightly to ensure that it spreads to the edges without leaking beyond the specimen.
- Immediate neutralization for control samples
For the control (untreated) samples, 10 mL of SCDLP broth or another appropriate neutralizing agent is added immediately after the application of the inoculum.
- Incubation
Treated and control samples are placed in the incubator at 25°C with a relative humidity of 90% for a contact period of 24 hours. The contact time may vary depending on the manufacturer’s instructions, but typically 24 hours serves as the common standard.
- Recovery of virus after incubation
After incubation, 10 mL of neutralizing broth is added to both treated and control samples to recover any remaining active virus from the surface. The neutralizing solution is then serially diluted up to 10 dilutions.
- Virus quantification
The infectious titre of the isolated virus is determined by using assays such as the Plaque Assay or TCID50 assay. These methods allow quantification of the virus and evaluate its ability to infect host cells after the 24-hour contact period.
- Calculation of antiviral activity: The antiviral activity of the treated surface is determined based on the equation,
R = Log10(Ut) – Log10(At)
Where:
- R is the antiviral activity value.
- Log10(Ut) is the logarithmic average of the infectivity titer of the virus after the specific contact time with the untreated control specimen.
- Log10(At) is the logarithmic average of the infectivity titer of the virus after the specific contact time with the treated test specimen.
Passing criteria
The result of the assay is expressed in terms of a log reduction value, which represents the number of inactivated or killed viruses. A high log reduction implies more virucidal activity. For the material to pass the ISO21702 virucidal efficacy testing, there should be a log reduction of 2 or more in the viral particles.
Importance of ISO 21702 test
ISO standard 21702 is an important test as it provides quantitative results for the antiviral efficacy of treated materials. This information is critical for product developers, regulatory bodies, and consumers alike. The test indirectly contributes to the reduction of viral infections in healthcare settings and public spaces by confirming the efficacy of surfaces treated with antiviral agents.
Compliance and industry standards for ISO 21702 test procedure
Compliance with the ISO standard allows manufacturers to market their products confidently as “antiviral products.” The standard is internally recognized and serves as a benchmark for testing antiviral activity. This standard ensures regulatory compliance and helps gain consumer trust in the product’s efficacy. Most industries, particularly healthcare, construction, and consumer goods, require compliance with ISO standards to meet safety and quality guidelines.
Strengths of ISO 21702 Test Standard
- Standardized approach: Illustrates a very clear and consistent methodology for the determination of antiviral activity of nonporous surfaces.
- Reliable results: The standardized methodology delivers scientifically reproducible and reliable results of the test.
- Versatile application: It provides flexibility in testing different viruses and product types.
- Internationally recognized: The standard is widely accepted across various industries and regions, rendering it valuable to global compliance and product validation.
Benefits of ISO 21702
- Increased product credibility: Testing helps validate the antiviral effectiveness of the products, which increases the customer’s trust.
- Regulatory compliance: Testing helps manufacturers meet global regulatory requirements for antiviral-treated surfaces.
- Supports the product claims: Provides scientific evidence of antiviral efficacy required to support product claims and for marketing.
- Improved public health: It indirectly contributes towards the reduction of viral transmission on frequently touched surfaces in public and healthcare settings.
Conclusion
The ISO test is a vital tool for ensuring the efficacy of antiviral-treated surfaces in reducing viral load on non-porous surfaces. It gives a standardized method by which developers can test the efficacy of their products for reduced viral activity, providing safer and more effective products to meet the rapidly growing need for antiviral protection.
At Microbe Investigations, we conduct ISO 21702 testing on a wide range of plastic and non-porous surfaces, including coatings, metal substrates, ceramics, natural and synthetic leather, rubber, and more. Our team of skilled microbiologists and technical experts is dedicated to delivering high-quality assurance testing.
In addition, our state-of-the-art testing facilities offer comprehensive antimicrobial testing for textiles, coatings, and surface disinfectants.
For more information about our antimicrobial testing services, please contact our experts today.
FAQs
The ISO 21702 is a test method for measuring antiviral activity on plastics and other non-porous surfaces of antiviral-treated products against specified viruses.
The ISO 21702 can be used to evaluate antiviral activity on plastics and other non-porous surfaces such as coating materials, metal substrates, ceramics, natural and artificial leather, rubber, etc.
The turnaround time for ISO 21702 test is 4 weeks. We also offer “Fast Track” program, where the turnaround time is 2-3 weeks depending on the virus strain.
At Microbe Investigations, we understand the need for accuracy and speed. We test for the ISO 21702 using the following viruses: SARS CoV-2 (Omicron, Delta, Wuhan variant), Betacoronavirus 1 (OC43) (ATCC VR-1558), Human coronavirus 229E (ATCC VR-740), Influenza A (H1N1) (ATCC VR-1469), Influenza A (H3N2) (ATCC VR-1679), Human Poliovirus type 1 (LSc-2ab), Human Adenovirus type 5 (ATCC VR-5), Murine Norovirus (S99), Vaccinia virus (ATCC VR-1549), and Feline calicivirus (strain F-9).
Non-porous surfaces, such as plastics, rubbers, ceramics, and treated metals, can be tested using this standard.
The test involves applying a virus to a treated surface, incubating it, and measuring the reduction in viral activity compared to a control surface.
Key parameters of this test include the type of virus, concentration of the virus ( virus titer), incubation period, and the recovery of the virus after incubation.
While ISO 21702 is used to measure the antiviral activity, ISO 22196 tests for antibacterial activity on plastics and other non-porous surfaces. Both of the above standards offer a valid method for determining antimicrobial activity, but they differ based on the type of pathogen tested.
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