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Material Compatibility Test
Evaluation of compatibility of disinfectant towards the material it disinfects.
“How can we know which material is our new disinfectant compatible with?” – Household and medical disinfectants contain mixtures of active ingredients, surfactants and solvents that have the potential of damaging certain materials over time. This can lead to not only visual and physical modifications but also possible loss of functionality of the particular surface. Therefore, material compatibility test is developed to help manufacturers avoid such situations.
Material compatibility test is generally required to be performed in the EU region, quoting the European Medical Device Regulation, Annex I, Chapter II, Clause 10.3,
“Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use”This may not be a mandatory regulation in some regions but it is always encouraged to determine the suitability of your disinfectant when using on the intended materials. In TECOLAB, we practice the standard method EN ISO 21530 which was established to test the material compatibility of dental equipment towards disinfectants. Besides dental equipment, this test method can be adapted for other materials as well.
Some Materials Available for Compatibility Testing
| Type of Materials | Examples of Equipment |
| Aluminium | Walker, seating, endoscope, surgical tray |
| Glass | X-ray shield, glass partition, wall panel |
| Stainless steel | Wheelchair, bed frame, trolley, IV stand, scalpel |
| Vinyl fabric | Furniture, curtain |
| Acrylics (PMMA) | Incubator, x-ray protective shield, isolette |
| ABS (Acrylonitrile butadiene styrene) | Keyboard, medical devices for blood access |
| PVC (Polyvinyl chloride) | Wall covering, mattress cover, flooring |
| Aluminium silicate | Crutches, stretcher, instrument tray |
Type of Test
There are 3 different methods in performing the material compatibility test, immersion test, spray test and contact test. The choice of test depends on manufacturer’s instruction on how the disinfectant is applied onto the surface. The infographic below briefly shows how each method is carried out.
Inspection and Evaluation Criteria
Visual Inspection – assessed by observing any visible changes based on:
- Surface Structure
- Surface Color
- Surface Shine
Tactile Inspection – assessed by using sense of touch using fingers or any appropriate probe based on:
- Surface Texture
- Surface Tackiness
- Surface Hardness
Diagram below shows the example of results obtained from partially immersion test on aluminium.
Generally, material compatibility testing can be useful for manufacturers to identify the type of material that is compatible with their disinfectants which enhances the marketability of the disinfectant when users are ensured of what is best for their equipment. Contact us now for more information!
Going Beyond Standard Compatibility Testing
If you would like to further evaluate your materials to identify potential hidden vulnerabilities that the above standard might not capture, we recommend considering the Bend Test. In this test, materials are clamped onto specific strain jigs to maintain them in a bent position. A cotton pad soaked with the chemical is then placed on the surface of the material.
The key difference between the contact test (as per ISO 21530) and the Bend Test is that the former evaluates the material in a flat state, whereas the latter introduces bending stress, which may reveal additional weaknesses under pressure.
To learn more, feel free to click on Bend Test.