To harmonize requirements for contact lenses, care products and accessories around the world, ISO developed ISO 14534:2011, Ophthalmic optics – Contact lenses and contact lens care products – fundamental requirements. Now in its third edition, the standard has been technically revised to bring it up to date with the latest industry developments.
ISO 14534 specifies safety and performance requirements for contact lenses and related products, such as the need for risk assessment, specifications for design, materials, clinical evaluation and manufacturing, microbiological requirements, packaging, shelf-life and discard date and labeling.
Imre Kovats, Project Leader for the standard, explains “In addition to stating requirements, ISO 14534 references all relevant International Standards for contact lenses, whether for determining shelf-life, or specifying medical symbols. This makes it an indispensable tool for the contact lens industry. It is also useful for regulators wishing to harmonize requirements with international best practice and to promote global trade. Finally, consumers will benefit from clear, straightforward requirements that are same around the world.”
ISO 14534:2011, Ophthalmic optics – Contact lenses and contact lens care products – fundamental requirements, was prepared by ISO technical committee ISO/TC 172, Optics and photonics, subcommittee SC 7, Ophthalmic optics and instruments. The standard is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 66 Swiss francs through the ISO Store or by contacting the Marketing, Communication & Information department (see right-hand column).