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ISO 22196: 2007 – Determination of Antibacterial Efficacy of Plastic Surfaces
ISO 22196 is an internationally accepted standard that provides the test conditions and requirements for assessing the antibacterial efficacy of treated plastic materials. The standard quantifies the reduction of bacterial growth on treated surfaces. The test results can be used by manufacturers to make informed decisions about the efficacy, quality and safety of the product.
ISO-22196 test is a harmonized version of the Japanese standard JIS Z 2801 which provides guidelines for testing the antibacterial efficacy of plastic material.
ISO 22196 test methods and requirements
Sample preparation
- Test samples: 3 treated samples.
- Control sample: 6 untreated samples. Three samples are used for assessing the viable microbial count immediately after inoculation, while the remaining three are used to estimate the viable microbial count after 24 hours of incubation.
Note – Both treated and untreated samples should be 50mm x 50mm in size and not more than 10 mm in thickness. All the test specimens are kept separately in sterile petri plates to avoid cross-contamination.
ISO 22196 test procedure
- The test bacterial inoculum is inoculated onto the treated and untreated test samples and covered with a piece of inert film of size 40 mm × 40 mm to prevent the spread of inoculum from the edges.
- These petri plates are then incubated at specific temperature conditions (35°C) and humidity for 24 hours.
- For untreated samples (control): Immediately after incubation, 10 ml of SCDLP (Soya Caesin Digest Lecithin Polysorbate) broth (which serves as a neutralizer) is added to the Petri plates containing the sample material. Further, a 10-fold serial dilution is performed with the recovered neutralizing solution to enumerate the viable bacteria. Tryptic Soya Agar (TSA) is used as the culture media for the growth of bacteria and the plates are incubated for 40-48 hours at 35 °C.
- For treated samples (test): 10 ml of SCDLP broth (used as a neutralizer) is added to Petri plates having samples after the incubation of 24 hours. Further, 10-fold serial dilution is performed and viable bacteria are enumerated by Plate Count method.
- Plates are incubated at 35 °C for 40 hours to 48 hours. After incubation, CFU (Colony Forming Unit) is counted on plates (sample and control) containing 30 – 300 colonies.
- The bactericidal activity of the testing material is determined by comparing the reduction in viable bacterial count of treated samples with control samples.
Compliance and industry standards for ISO 22196 testing
The standard is widely accepted in most industries, notably in healthcare, consumer goods and food packaging, among others. Compliance with this standard ensures that a product shall meet international standards for antibacterial performance. For manufacturers who aim to export their products or sell them to sectors with strict hygiene requirements, testing their products will be beneficial.
Factors affecting the validity of ISO 22196 test method
There are various factors that could potentially influence the validity and accuracy of the test method. Therefore, these factors must be considered during the testing process to ensure the validity of the results.
Impact of contact time
The contact time between the bacterial suspension and the plastic surface can also be another factor that might have an important effect on the test outcome. Longer contact times generally result in more decreased growth of bacteria, while shorter exposure times might not offer enough time for the desired interaction of the antibacterial agent with microorganisms.
Effect of Surface Topography
Surface topography may include features such as roughness or smoothness of the material. These factors may influence the adhesion and growth of bacteria. Rough surfaces might form some micro-environments that protect bacteria from the action of the antibacterial agent which is not possible in the case of smooth surfaces. Thus, the action of antibacterial agents is better in the case of smooth surfaces in comparison to rough surfaces. This variability must be accounted for while testing.
Influence of temperature and humidity
Other factors may also impact bacterial growth and the efficacy of antibacterial agents. The experiment is conducted in a controlled environment to eliminate the variability that arises due to temperature and humidity fluctuation. However, the difference between temperatures and humidities in practical applications should also be considered during the evaluation of the test results.
Strengths of ISO 22196 test method
ISO-22196 is considered to be a reliable method of assessing the antibacterial activity of plastic surfaces. The test yields quantitative results and, therefore, can be used to compare the efficacy of various antibacterial treatments. Therefore, the standard is one of the important tools for manufacturers who aim to claim the antibacterial properties of their products.
The method also offers flexibility in testing different types of plastic materials ranging from rigid surfaces to flexible films. Thus, the method can be used to test a variety of products such as food packaging, medical devices and household commodities.
Advantages of ISO 22196 testing
Validation of antibacterial claims
Testing conducted using this standard allows the manufacturer to validate their claims of the antibacterial efficacy of the product, thus satisfying regulatory requirements as well as gaining customer trust.
Regulatory compliance
Products that meet the requirements of this standard have a better chance of complying with the regulations in various markets and this compliance is often necessary for product approval and market entry, especially in industries with stringent hygiene standards.
Competitive advantage
Manufacturers can use it as a marketing tool to differentiate their products from competitors. Demonstrating compliance with international standards can enhance brand reputation and consumer confidence.
Enhanced product development
The test provides critical information required for improving and optimizing the antibacterial treatment at the product development stage. It helps in driving innovation in product development.
Risk reduction
The test reduces the chances of bacterial contamination as it detects and quantifies the antibacterial activity of treated surfaces. For products used in areas where the need for infection control is a critical factor, this testing plays a critical role in validating the efficacy of such products.
Transparency and credibility
The standardized approach of the standard ensures transparency in the test, thus making it easy for stakeholders to understand and trust the data. This kind of transparency and credibility is mainly important for regulatory bodies, consumers, and business partners.
Conclusion: The importance of ISO 22196 testing for antibacterial plastic surfaces
ISO-22196 has been established as a benchmark test to determine the effectiveness of antibacterial plastics. This process ascertains that the claims of antibacterial properties by the manufacturers are valid and also help meet the industrial and regulatory standards. Demonstrating such compliance also allows companies to avoid legal risks, and stay ahead in a competitive marketplace where hygiene is a prime concern.
MIS is a global microbiology test service provider specializing in testing for textiles, plastics, coatings and surface disinfectants. With a team of highly experienced microbiology professionals and well-equipped laboratory facilities, we aim to provide maximum efficacy and accuracy at an affordable price.
For more information on the ISO 22196 test, please contact us today. Our team of highly qualified professionals is committed to understanding your needs and delivering the best possible outcomes.
FAQs
ISO 22196 is a quantitative test used to determine the ability of plastic materials to kill bacteria (bactericidal) or inhibit their growth (bacteriostatic).
At Microbe Investigations, we test for the ISO 22196 using the following bacterial strains: Pseudomonas aeruginosa (ATCC 15442), Escherichia coli (ATCC 8739), Staphylococcus aureus (ATCC 6538P), Enterococcus hirae (ATCC 10541), Klebsiella pneumoniae (ATCC 4352), MRSA (ATCC 33591), Salmonella enterica ( ATCC 10708), Candida albicans (MTCC 3017). Additional strains can be added at the customer’s request.
It takes 3 to 4 days to complete this test.
ISO 22196 testing is specifically designed for evaluating the antibacterial activity of plastic products and other non-porous materials. While it does not explicitly mention medical devices it can be applied to any non-porous materials which may include certain consumer products and potential medical devices if they are made from or incorporate treated plastics.
ISO 22196 focuses on the measurement of antibacterial activity on the surfaces of treated plastics by comparing the viable cell count of bacteria on treated versus untreated samples after incubation. Other tests like those specified in ISO 846, evaluate the degradation of plastics due to bacterial or fungal growth.
Product samples should be prepared as flat specimens typically 50 mm × 50 mm with a thickness of not more than 10 mm. The samples should be free from contamination and organic debris and should not come into contact with each other during preparation. If necessary specimens can be cleaned or sterilized prior to testing but any cleaning methods should be documented in the test report.
ISO 22196 is developed for antibacterial-treated plastic products and can also be applied to other non-porous products. It is not designed for porous surfaces.
The standard conditions involved in testing are using bacteria such as Staphylococcus aureus and Escherichia coli. Test specimens are inoculated with a bacterial suspension and covered with a film to ensure the bacteria spread to the edges. The inoculated specimens are incubated at 35 ± 1°C with relative humidity of not less than 90% for a period of 24 hours.
This testing assists in proving that the antibacterial-treated products are capable of effectively inhibiting bacterial growth on their surface thus enhancing the safety and hygiene of the products. This is especially crucial in products that come in contact with human skin or food as it helps prevent the spread of harmful bacteria.
Products tested include antibacterial plastic products available for use in industries such as consumer goods, medical purposes, food packaging and other areas where surface cleanliness plays a significant role.
ISO 22196 certification gives a confirmation of the antibacterial efficacy of plastic surfaces, and once products pass for this standard, they satisfy international hygiene requirements, which boosts customer confidence and aids in regulatory compliance.
A good result typically shows a significant reduction in bacterial growth, often measured as a logarithmic reduction. Higher the log reduction, better the efficacy.
Contact time, surface topography and environmental conditions like temperature and humidity can impact the effectiveness of the antibacterial treatment.
The test is specific to plastic and non-porous surfaces. It does not apply to porous materials or environments where multiple types of microorganisms may be present.
Yes, JIS Z 2801 is an alternative test used to evaluate antibacterial activity on different plastic materials.
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