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ISO 22196: 2007 – Determination of antibacterial efficacy of plastic surfaces
Microorganisms such as bacteria and fungi may persist on hard surfaces like plastics and other non-porous materials and remain infectious for several days. Therefore the aim of the development of antibacterial solid materials is to mitigate disease-causing microbes to ensure the public health safety. These products need to be tested for their antibacterial efficacy.
The ISO 22196 is designed to evaluate the efficacy of antibacterial-treated plastic and other non-porous materials in preventing microbial contamination. This test is a harmonized version of JIS Z 2801.
ISO 22196 Test Methods and Requirements
Sample Preparation
- Test samples – Requires at least 3 specimens from the treated test material.
- Control sample –Three untreated samples are used to assess the viable microbial count immediately after inoculation and the remaining three are used to determine the viable microbial count after 24 hrs of incubation.
Note – Both treated and untreated samples should not be more than 10 mm in thickness. All the test specimens are kept separately in sterile petri plates to avoid cross-contamination.
Test Procedure
- Test bacterial inoculum is placed on the testing samples (treated and untreated) and is covered with a piece of inert film (size of 40 mm × 40 mm) to prevent the inoculum from spreading through the edges.
These petri plates are incubated for 24 hrs at specific temperature (35°C) and humidity conditions. - For untreated samples (control) – Immediately after incubation, 10 ml of SCDLP broth (which serves as a neutralizer) is added to the Petri plates which contain 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 is 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 the evaluation of the reduction in viable bacterial count of treated samples as compared to the control samples.
Advantages of ISO 22196 test
Validation of antibacterial claims
Test done as per this standard helps manufacturers substantiate claims about the antibacterial properties of their products which is crucial for regulatory approval and consumer trust.
Regulatory compliance
Products that meet the requirements of this standard can more easily comply with regulatory requirements in different markets. 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 valuable data that can be used to improve and optimize antibacterial treatments during the product development phase. This scientific validation helps in refining formulations and manufacturing processes to achieve better antibacterial efficacy.
Risk reduction
By identifying and quantifying the antibacterial activity of treated surfaces the test helps mitigate risks associated with bacterial contamination. This is especially critical for products used in environments where infection control is paramount, such as hospitals and food processing facilities.
Transparency and credibility
The test’s standardized approach ensures transparency in testing results making it easier for stakeholders to understand and trust the data. This transparency is important for regulatory bodies, consumers and business partners.
We are a leading, global test service provider in the field of microbiology, 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 you can consult our experts. Our team of highly qualified professionals is always there to understand your needs and deliver the best 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.
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