ISO 15798:2010 眼科植入物 眼科手术用粘弹剂

标准编号：ISO 15798:2010

中文名称：眼科植入物 眼科手术用粘弹剂

英文名称：Ophthalmic implants — Ophthalmic viscosurgical devices

发布日期：2010-02

标准范围

ISO 15798:2010适用于眼科粘液外科设备（OVD），这是一类具有粘性和/或粘弹性特性的非活性外科植入物，拟用于人类眼前段的手术。OVD设计用于创造和维持空间，保护眼球内组织，并在手术期间操纵组织。ISO 15798:2010规定了这些设备制造商提供的预期性能、设计属性、临床前和临床评估、灭菌、产品包装、产品标签和信息的安全要求。

ISO 15798:2010 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.ISO 15798:2010 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

标准预览图