ISO 11539 Ophthalmic Optics, Contact Lenses, Standard Test for Classification of Contact Lenses and Contact Lens Materials

Medical Tests

ISO 11539 Ophthalmic Optics, Contact Lenses, Standard Test for Classification of Contact Lenses and Contact Lens Materials

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 11539 testing. This International standard describes a method for classifying contact lenses and the materials used in their manufacture. It allows for the proprietary and non-proprietary identification of the main chemical components of the material in a simplified form.

ISO 11539 Ophthalmic Optics, Contact Lenses, Standard Test for Classification of Contact Lenses and Contact Lens Materials

For hydrogel contact lens materials, the classification specifies whether the material is ionic and the range in which the material has water content. For non-hydrogel contact lens materials, the classification indicates the presence/absence of silicon/fluorine and oxygen permeability grouping.

The serial suffix is ​​also administered by the USAN council and is used where the original ratio of monomers of an existing contact lens polymeric material is changed to make a new contact lens polymeric material. In this case, a capital letter “A” is added after the body definition.

Subsequent changes in the monomer ratio are indicated by the next letter of the alphabet. These letters are used to distinguish copolymers with unchanged monomer units but in different proportions. In cases where there is only one unique monomer ratio, the serial suffix can be omitted.

The modification code is presented as a lowercase "m" and indicates that the contact lens has a modified surface with properties different from the bulk material. Examples of surface modification processes that the contact lens may undergo include: plasma treatment, acid/base hydrolysis, incorporation of a material that migrates to the surface, etc. Some types of colored contact lenses may also be considered surface modified. In the case of an unmodified surface, this suffix is ​​skipped.

EUROLAB assists manufacturers with ISO 11539 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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