This standard, together with ISO 15004-1 and ISO 15004-2:2007, specifies requirements and test methods for slit-lamp microscopes.
This standard is applicable to general slit-lamp microscope. This standard is not applicable to slit-lamp microscope accessories, e.g. photographic equipment and lasers.
This standard takes precedence over ISO 15004-1 and ISO 15004-2:2007, if differences exist.
2 Normative References
The following documents for the application of this document are essential. For dated references, only the edition cited applies. For undated references, the latest edition of the normative document (including any amendments) applies.
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety (GB 9706.1-2007, IEC 60601-1:1988, IDT)
ISO 15004-1 Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 1: General Requirements Applicable to All Ophthalmic Instruments
ISO 15004-2:2007 Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
slit-lamp microscope
instrument consisting of a microscope and a swivelling illumination system providing a slit image
