11 July 2011
With millions of people around the world using contact lenses, it is important to make sure that these are safe to wear. However, different countries may have different regulations, which creates confusion for manufacturers, suppliers, and even users. To harmonise 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. ISO 14534 has been technically revised to bring it up to date with the latest industry developments.
'In addition to stating requirements, ISO 14534 references all relevant international Standards for contact lenses, whether for determining shelf life, or specifying medical symbols,' says Imre Kovats, Project Leader for the Standard. 'This makes it an indispensable tool for the contact lens industry. It is also useful for regulators wishing to harmonise requirements with international best practice and to promote global trade. Finally, consumers will benefit from clear, straightforward requirements that are the same around the world.'
The Standard 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 labelling.
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