标准摘要
[中文适用范围]： 本文件规定了眼科仪器光学辐射安全的基本要求，并适用于所有将光学辐射导向或照射眼睛的眼科仪器。它也适用于所有新的和新兴的直接将光学辐射导向或照射眼睛的眼科仪器，以及用于诊断、照明、测量、成像或对准目的的治疗或手术系统的相关部分。注意 为了本文件的目的，光学辐射是指波长范围为250 nm至2500 nm。本文件不适用于治疗辐射。然而，在治疗装置的治疗束进行非目标组织风险评估时，如果垂直（仪器特定）国际标准中有不同于ISO 15004-2的具体光危害要求，则应优先采用这些垂直国际标准中的规定。本文件将眼科仪器分为第一组或第二组，以区分无害仪器和潜在有害仪器。 [外文原描述]： This document specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes. NOTE For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm. This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue. Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004-2, then those in the vertical International Standard take precedence. This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.
英文名称Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection