Z80.29-2015

Ophthalmics – Accommodative Intraocular Lenses (VC)


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标准号
Z80.29-2015
发布日期
2015年05月28日
实施日期
2015年11月18日
废止日期
中国标准分类号
/
国际标准分类号
/
发布单位
ANSI - American National Standards Institute
引用标准
46
适用范围
Scope and purpose This standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus. For the purposes of this standard@ these implants are referred to as accommodative intraocular lenses (AIOLs). This standard addresses specific requirements for AIOLs that are not addressed in the normative references@ and include vocabulary@ optical properties and test methods@ mechanical properties and test methods@ labeling@ biocompatibility@ sterility@ shelf-life and transport stability@ and clinical investigations necessary for this type of device. As with any standard@ alternative validated test methods may be used.




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