What is ISO 14534 - Requirements on contact lenses and contact lens care products about?
ISO 14534 is a European standard that discusses contact lenses and contact lens care products for ophthalmic optics. ISO 14534 outlines safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses to ensure the safety of the user’s eyes.
Note: ISO 14534 does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.
Who is ISO 14534 - Requirements on contact lenses and contact lens care products for?
ISO 14534 on requirements on contact lenses and contact lens care products for ophthalmic optics is useful for:
- Manufacturers of contact lenses and contact lens care products
- Medical laboratories
- Regulatory bodies
Why should you use ISO 14534 - Requirements on contact lenses and contact lens care products?
Ophthalmic optics is the science of visual perception and the physiology of the eyes. Contact lenses are plastic lenses that are placed directly on the surface of the eye to correct visual defects. Contact lenses and contact lens care products can easily get damaged and therefore proper acceptable performance is required for such products.
ISO 14534 guideline assists you with safety requirements, performance requirements, risk assessment, design, material, clinical evaluation, manufacturing, microbiological requirements, packaging, shelf life, discard date, labelling, and information to be supplied by manufacturers for contact lenses and contact lens care products for ophthalmic optics.
With compliance and obedience to ISO 14534, you can improve the performance and safety measures for contact lenses and contact lens care products that ensure the safety of users of contact lenses and contact lens care products.