标准号：ISO 15798-2010
实施状态：作废
中文名称：眼科植入物.眼科手术粘接器件
英文名称：Ophthalmic implants - Ophthalmic viscosurgical devices
发布日期：2010-01
被替代标准：ISO 15798-2013
代替标准：ISO 15798-2001;ISO/FDIS 15798-2009;ISO 15798 Technical Corrigendum 1-2003
采用标准：DIN EN ISO 15798-2010,IDT;BS EN ISO 15798-2010,IDT;EN ISO 15798-2010,IDT;NF S94-751-2010,IDT;OENORM EN ISO 15798-2010,IDT;PN-EN ISO 15798-2010,IDT;UNE-EN ISO 15798-2010,IDT
起草单位：ISO/TC 172
标准简介：This International Standard 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.
This International Standard 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.
文件格式：PDF
文件大小：227.10KB
文件页数：22
（以上信息更新时间为：2019-11-22）
ISO 15798-2010 眼科植入物.眼科手术粘接器件.pdf
(227.1 KB)
|
|
