C32 眼科与耳鼻咽喉科手术器械 标准查询与下载

ISO 15798:2010 眼科植入物.眼科手术粘接器件

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.

Ophthalmic implants - Ophthalmic viscosurgical devices

ANSI Z80.9-2010 助视器

This Standard applies to optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low-vision devices. It specifies optical and mechanical requirements and test methods. It includes devices with optical and/or electrical and/or electronic components used for image capture or display.

Low Vision Devices

ANSI Z80.1-2010 处方眼镜镜片

This standard applies to the processing of all prescription ophthalmic spectacle lenses in edged or assembled form. It is a processing guideline for optical laboratories applicable to prescription eyewear prior to transfer for dispensing and for the dispenser prior to the delivery of the finished eyewear to the patient. Relevant optical specifications and tolerances of this standard should apply also to uncut lenses supplied by an optical laboratory to be used in filling a specific prescription.

Prescription Spectacle Lenses

ISO 9801:2009 眼科仪器.测试箱镜头

Ophthalmic instruments - Trial case lenses

DIN 96067:2009 医疗器械.Lucae式耳钩

Medical instruments - Ear hook type Lucae

BS EN ISO 8612:2009 眼科仪器.眼压计

Ophthalmic instruments - Tonometers

NF S12-121:2009 眼科器械.检眼计

Ophthalmic instruments - Ophthalmometers.

DIN EN ISO 10341:2009 眼科器械.折射头(ISO 10341:2009),EN ISO 10341:2009的德文版本

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 10341:2009); English version of DIN EN ISO 10341:2009-10

ISO 8612:2009 眼科设备.张力计

Ophthalmic instruments - Tonometers

DIN EN 80601-2-58:2009 医疗电气设备.第2-58部分:眼外科用透镜拆卸装置和玻璃体切除装置基本安全和必要性能的详细要求(IEC 80601-2-58-2008).德文版本EN 80601-2-58-2009

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 (IEC 80601-2-58:2008); German version EN 80601-2-58:2009

DIN EN ISO 10343:2009 眼科器械.折射头(ISO 10343:2009),德文版本EN ISO 10343:2009

This International Standard, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer (designated as code 1 in Table 1) are capable of measuring radii of curvature of contact lenses as described in ISO 18369-3:2006. 4.1. It is assumed that the Iocat corneal front surface and both contact lens surfaces are spherical or toroidak This international Standard takes priority over ISO 15004-1, if differences exist.

Ophthalmic instruments - Ophthalmometers (ISO 10343:2009); English version of DIN EN ISO 10343:2009-10

DIN EN ISO 15254:2009 眼科光学技术和仪器.提高近视用电子光学装置(ISO 15254:2009),EN ISO 15254:2009的德文版本

This International Standard applies to electro-optical devices specified by the manufacturer for use by visually impaired persons, as low-vision aids. It specifies electro-optical and mechanical requirements and test methods. This International Standard does not cover optical devices for enhancing low vision which are specified in ISO 15253

Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009); English version of DIN EN ISO 15254:2009-10

DIN EN ISO 8596:2009 眼科光学.视觉灵敏度测试.标准验光字体及其演示(ISO 8596:2009),DIN EN ISO 8596:2009-10的英文版本

This International Standard specifies a range of Landolt ring optotypes and describes a method for measuring distance visual acuity under daylight conditions for the purposes of certification or licensing. It is neither intended as a standard for clinical measurements nor for the certification of blindness or parcia sight For the purposes of measuring visual acuity, the standard optotype should be used. For clinical use, see the recommendation prepared by the Visual Functions Committee of the Internationa Council of Ophthalmology[1].

Ophthalmic optics - Visual acuity testing - Standard optotype and its presentation (ISO 8596:2009); English version of DIN EN ISO 8596:2009-10

BS EN ISO 10940:2009 眼科仪器.眼底检查镜

This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis. This International Standard is not applicable to the following instruments: ⎯ those that contact the eye during the examination; ⎯ those using scanning laser sources. This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Ophthalmic instruments - Fundus cameras

BS EN ISO 10944:2009 眼科器械.斜视诊疗器

This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop the patient's binocular vision and to measure horizontal, vertical and cyclo deviation in different positions of gaze. This International Standard takes precedence over ISO 15004-1, if differences exist.

Ophthalmic instruments - Synoptophores

NF S12-300-1:2009 眼科器械.基本要求和测试方法.第1部分:适用于所有眼科器械的一般要求

Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments.

NF S94-750-8:2009 眼科植入物.人工晶状体.第8部分:基本要求

Ophthalmic implants - Intraocular lenses - Part 8 : fundamental requirements.

ISO 10944:2009 眼科器械.斜视诊疗器

This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop the patient's binocular vision and to measure horizontal, vertical and cyclo deviation in different positions of gaze. This International Standard takes precedence over ISO 15004-1, if differences exist.

Ophthalmic instruments - Synoptophores

ISO 10940:2009 眼科仪器.眼底照相机

This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis. This International Standard is not applicable to the following instruments: ⎯ those that contact the eye during the examination; ⎯ those using scanning laser sources. This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Ophthalmic instruments - Fundus cameras

BS EN ISO 15004-1:2009 眼科器械.基本测试方法和要求.第1部分:适用于所有眼科器械的一般要求(ISO 15004-1-2006)

This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. This part of ISO 15004 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)