ISO 15004-1 discusses ophthalmic instruments. ISO 15004-1 outlines requirements for non-invasive, active, and non-active ophthalmic instruments and devices for enhancing low vision. ISO 15004-1 is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
Note: ISO 15004-1 does not apply to operation microscopes, endoscopes, and devices intended for laser investigation or laser treatment of the eye.
ISO 15004-1 on ophthalmic instruments is useful for:
Ophthalmic instruments are devices designed to have an application to the eye. The ophthalmic instrument is intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a patient. Or for the compensation or alleviation of a disease, injury, or disability.
ISO 15004-1 guidelines help you with requirements, design, performance, protection against contaminants, thermal hazards, mechanical hazards, and electrical safety for ophthalmic instruments. ISO 15004-1 also provides test methods and requirements for information supplied by manufacturers of ophthalmic instruments. This ensures that general requirements are met by manufacturers of ophthalmic instruments.
BS EN ISO 15004-1:2020 supersedes ISO 15004-1:2006, which has been withdrawn. BS EN ISO 15004-1:2020 has some technical changes with respect to ISO 15004-1:2006. These include:
EN ISO 15004-1
ISO 15004-1