A medical device laboratory is needed to conduct ISO 11981-compliant testing on over-the-counter (OTC) dry eye formulations to evaluate their compatibility with contact lenses. The testing must follow the guidelines specified in ISO 11981: Ophthalmic optics – Contact lenses and contact lens products – Determination of physical compatibility of contact lens care products with contact lenses. Additionally, relevant performance characteristics should be assessed based on the properties and test methods outlined in ISO 18369-3:2017.
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