标准摘要
[中文适用范围]： 本文件规定了用于确定接触镜和接触镜护理产品的安全性和性能的临床研究（CI）的要求和指南。 注1 本文件试图协调全球范围内对接触镜和接触镜护理产品的营销和标签要求所进行的临床研究的公认监管要求。然而，各国的要求差异很大。当国家实践或法规规定某些法律要求时，这些要求优先于本文件。 注2 对于超出屈光不正矫正的适应症，临床研究计划（CIP）中应包括对安全性和性能的额外考虑。 [外文原描述]： This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products. NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document. NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).
英文名称Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations