Optics, optical instruments and implants

If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:

• Active Implantable Medical Devices (AIMDD) Council Directive 90/385/EEC (1990)
• Medical Devices Directive (MDD) Council Directive 93/42/EEC (1992)
• In Vitro Diagnostic Directive (IVDD) Council Directive 98/79/EC (1998).

BSI's standards specify minimum requirements and test methods for ophthalmic instruments, ophthalmoscopes and opthalmic implants.

 
BS EN ISO 15004-2:2007
Ophthalmic instruments. Fundamental requirements and test methods, Light hazard protection

BS EN ISO 15004-1:2009
Ophthalmic instruments. Fundamental requirements and test methods. General requirements applicable to all ophthalmic instruments

BS EN ISO 10341:2009
Ophthalmic instruments. Refractor heads

BS EN ISO 15254:2009
Ophthalmic optics and instruments. Electro-optical devices for enhancing low vision

BS EN ISO 11981:2009
Ophthalmic optics. Contact lenses and contact lens care products. Determination of physical compatibility of contact lens care products with contact lenses

BS EN ISO 14534:2009
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements

BS EN ISO 12870:2009
Ophthalmic optics. Spectacle frames. Requirements and test methods

BS EN ISO 10944:2009
Ophthalmic instruments. Synoptophores

BS EN ISO 10940:2009
Ophthalmic instruments. Fundus cameras

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