ISO 15798:2013适用于眼科粘膜手术装置(OVD),一类具有粘性和/或粘弹性质的非活性手术植入物,用于在人眼前段手术中使用。 OVD设计用于创建和维持空间,以保护眼内组织并在手术过程中操纵组织。
ISO 15798:2013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性要求
ISO 15798:2013 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 15798:2013 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.