C32 眼科与耳鼻咽喉科手术器械 标准查询与下载

ISO 10341:2012 眼科仪器.折射头

This International Standard specifies requirements and test methods for refractor heads used for the determination of refractive errors and binocular functions of the human eye. This International Standard takes priority over ISO 15004-1, if differences exist.

Ophthalmic instruments - Refractor heads

ISO 22665:2012 眼科光学和仪器.眼镜轴向距离的测量仪器

This International Standard is applicable to instruments and methods used for measuring the axial length of the human eye. It defines minimum requirements for such instruments and systems and defines test methods and procedures to verify that a system or instrument qualifies as an axial length measuring device in accordance with this International Standard.

Ophthalmic optics and instruments - Instruments to measure axial distances in the eye

NF S94-750-1:2012 眼科植入物.人工晶体.第1部分:词汇

Ophthalmic implants - Intraocular lenses - Part 1: vocabulary

BS EN ISO 9394:2012 眼科光学. 接触镜片和接触镜片护理产品. 通过兔眼视觉研究测定生物适合性

Ophthalmic optics. Contact lenses and contact lens care products. Determination of biocompatibility by ocular study with rabbit eyes

BS EN ISO 11979-1:2012 眼科植入物. 眼内透镜. 词汇

Ophthalmic implants. Intraocular lenses. Vocabulary

ISO 11979-4:2008/Amd 1:2012 眼科植入物.人工晶体.第4部分:标签和信息.修改件1

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information; Amendment 1

ISO 11979-1:2012 眼科植入物.人工晶体.第1部分:词汇表

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary

DIN EN ISO 8980-3:2012 眼科光学. 非切割精加工眼镜镜片. 第3部分: 透光性规范和试验方法(ISO/DIS 8980-3.2-2012); 德文版本prEN ISO 8980-3-2012

Ophthalmic optics - Uncut finished spectacle lenses - Part 3: Transmittance specifications and test methods (ISO/DIS 8980-3.2:2012); German version prEN ISO 8980-3:2012

BS EN ISO 11987:2012 眼科光学. 接触镜片. 储藏寿命的测定

Ophthalmic optics. Contact lenses. Determination of shelf-life

NF C74-395/A11:2012 医疗电气设备 - 第2-58部分: 眼科手术用晶状体移除装置和玻璃体切除装置基本安全和主要性能的特殊要求.

Medical electrical equipment - Part 2-58 : particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery.

DIN EN ISO 19980:2012 眼科仪器. 角膜外形素描系统 (ISO 19980-2012); 德文版本EN ISO 19980-2012

Ophthalmic instruments - Corneal topographers (ISO 19980:2012); German version EN ISO 19980:2012

DIN EN ISO 11979-7:2012 眼科植入物.眼内透镜.第7部分:临床研究

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006 + Amd 1:2012); German version EN ISO 11979-7:2006 + A1:2012

NF S12-135:2012 眼科设备.角膜外形测量系统

Ophthalmic instruments - Corneal topographers.

BS EN ISO 19980:2012 眼科仪器. 角膜外形素描系统

Ophthalmic instruments. Corneal topographers

ISO 19980:2012 眼科设备.角膜外形测量系统

This International Standard specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this International Standard and thus qualifies as a CT according to this International Standard. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This International Standard defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This International Standard is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. It is not applicable to ophthalmic instruments classified as ophthalmometers. The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 corneal apex location on the corneal surface where the mean of the local principal curvature is greatest 3.2 corneal eccentricity ec eccentricity, e, of the conic section that best fits the corneal meridian of interest NOTE If the meridian is not specified, the corneal eccentricity is that of the flattest corneal meridian (see Table 1 and Annex A). 3.3 corneal meridian θ curve created by the intersection of the corneal surface and a plane that contains the corneal topographer axis NOTE 1 A meridian is identified by the angle θ, that the plane creating it makes to the horizontal (see ISO 8429). NOTE 2 The value of θ, for a full meridian, ranges from 0° to 180° . 1

Ophthalmic instruments - Corneal topographers

NF S94-750-7/A1:2012 眼科植入物.眼内透镜.第7部分:临床调查.修改件1

Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations - Amendment 1.

ISO 23599:2012 盲人和视力受损人员用辅助产品. 行走表面感触指示灯

Assistive products for blind and vision-impaired persons - Tactile walking surface indicators

ISO 11979-7:2006/Amd 1:2012 眼科植入物.眼内透镜.第7部分:临床检测.修改件1

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations; Amendment 1

ANSI Z80.11-2012 眼角膜再造的激光设备

This standard applies to any laser system whose primary intended use is to alter the shape of the cornea through the removal of corneal tissue, resulting in the improvement of visual performance. This standard addresses the vocabulary, performance requirements, labeling, and clinical investigations necessary for this type of device.

Laser Systems for Corneal Reshaping

YY/T 0176.9-2011 眼用剪

本标准规定了眼用剪的标记与型式、要求、试验方法、检验 规则、标志、包装、运输与贮存。 本标准适用于剪切眼内虹膜、角膜、小梁、膜状内障和结膜的眼用剪。

Ophthalmic scissors