Standard No.:	YY 0290.8-1997
English Name:	Intraocular lenses―Part 8:Fundamental requirements
Chinese Name:	人工晶体 第8部分:基本要求
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	China Food and Drug Administration
Issued on:	1997-05-27
Implemented on:	1997-7-1
Status:	superseded
Superseded by:	YY 0290.8-2008 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirement
Superseded on:	2010-6-1
Abolished on:	2010-06-01
Language:	English
File Format:	PDF
Word Count:	2000 words
Price(USD):	224.00
Delivery:	via email in 1~3 business day

本标准规定了人工晶体的性能和设计、材料、临床评价、制造、灭菌、包装和有效期、标签、检验报告等内容。
本标准适用于手术植入人眼内前段的所有类型的人工晶体，但不包括角膜植人物。
注:如果本标准引用的标准中规定的测试方法不适用于某一特别设计或应用，则人工晶体生产者必须建立合适的其他测试方法并给出该方法的验证和理由.