标准号：ISO 15798-2001
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：2001-06
被替代标准：ISO 15798-2010
代替标准：ISO/FDIS 15798-2001
采用标准：DIN EN ISO 15798-2001,IDT;BS EN ISO 15798-2001,IDT;EN ISO 15798-2001,IDT;EN ISO 15798/AC-2005,IDT;NF S94-751-2001,IDT;SN EN ISO 15798-2001,IDT;SN EN ISO 15798/AC-2005,IDT;OENORM EN ISO 15798-2001,IDT;OENORM EN ISO 15798-2005,IDT;UNE-EN ISO 15798-2002,IDT;GOST R 53078-2008,IDT
起草单位：ISO/TC 172
标准简介：This International Standard applies 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. OVDs are not designed to have any pharmacological effect.
This International Standard defines 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：854.33KB
文件页数：26
（以上信息更新时间为：2019-11-23）
ISO 15798-2001 眼科植入物 眼科手术粘接器件.pdf
(854.33 KB)
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