This standard specifies the basic requirements for non-invasive, active and non-active ophthalmic devices. This standard is applicable to low-vision aids and tonometers, but not to other ophthalmic devices used in contact with the eye. This standard is an alternative to other general standards described in Section 2 if they are inconsistent in their contents. These requirements take precedence. This standard is not applicable to the work of operating microscopes, endoscopes and instruments for laser exploration or ocular laser procedures.
KS B ISO 15004:2013 history
2023KS B ISO 15004-2023 Ophthalmic instruments — Fundamental requirements and test methods
0000 KS B ISO 15004-2013(2018)
2013KS B ISO 15004:2013 Ophthalmic instruments ― Fundamental requirements and test methods
2003KS B ISO 15004:2003 Ophthalmic instruments-Fundamental requirements and test methods