C32 眼科与耳鼻咽喉科手术器械 标准查询与下载

BS EN ISO 15254:2009 眼科光学仪器.提高低度视力的电光装置

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

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)

BS EN ISO 8596:2009 眼科光学.视力测试.标准视力表及其表示(ISO 8596-2009)

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 partial 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 International Council of Ophthalmology.

Ophthalmic optics - Visual acuity testing - Standard optotype and its presentation(ISO 8596:2009)

DIN EN ISO 15004-1:2009 眼科仪器的基本要求和测试方法.第1部分:适用于所有眼科仪器的通用要求(ISO 15004-1:2006),DIN EN ISO 15004-1:2009-07的英文版本

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); English version of DIN EN ISO 15004-1:2009-07

ISO 15254:2009 眼科光学和仪器.提高低度视力的电光装置

Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision

ISO 10343:2009 眼科仪器.检眼仪

Ophthalmic instruments - Ophthalmometers

ISO 10341:2009 眼科仪器.折射头

Ophthalmic instruments - Refractor heads

BS EN ISO 11979-8:2009 眼科用植入物.眼内透镜.第8部分:基本要求(ISO 11979－8-2006)

This part of ISO 11979 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

Ophthalmic implants — Intraocular lenses Part 8: Fundamental requirements (ISO 11979-8:2006)

NF C74-395:2009 医疗用电气设备.第2-58部分：眼外科手术用镜头移动设备和玻璃体切除术设备基本性能和基本安全特殊要求

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

BS EN 80601-2-58:2009+A11:2011 医疗电气设备.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基本性能的特殊要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

BS EN 80601-2-58:2009 医疗电气设备.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基本性能的特殊要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard.

Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

DIN EN ISO 11979-4:2009 眼科植入物 眼内晶状体 第4部分:标注和信息

This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging. NOTE This part of ISO 11979 attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there might be additional national requirements.

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008); English version of DIN EN ISO 11979-4:2009-03

DIN EN ISO 12866:2009 眼科设备.视野镜

This International Standard specifies requirements and test methods for instruments designed to assess differential light sensitivity in the visual field by the subjective detection of the presence of test stimuli on a defined background. It does not apply to clinical methodologies and other psychophysical tests of the visual field This International Standard takes precedence over ISO 15004, if differences exist.

Ophthalmic instruments - Perimeters (ISO 12866:1999+Amd1:2008) (includes Corrigendum AC:2000+Amendment A1:2008); English version of DIN EN ISO 12866:2009-03

BS EN ISO 11979-4:2008 眼科植入物.眼内透镜.标记和信息

Ophthalmic implants - Intraocular lenses - Labelling and information

BS EN ISO 11979-4:2008+A1:2012 眼科植入物.眼内透镜.标记和信息

Ophthalmic implants. Intraocular lenses. Labelling and information

ANSI Z80.28-2009 眼的光学象差报告用方法

This standard specifies standardized methods for reporting the optical aberrations of eyes.

Methods for reporting optical aberrations of eyes

ANSI Z80.10-2009 眼科仪器.眼压计

This standard, together with ISO15004-1:2006 Fundamental requirements and test methods - Part 1: General requirements applicable to all instruments - First edition, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP) for the detection, diagnosis, and management of ocular abnormalities.

Ophthalmic Instruments - Tonometers

ISO 11979-4:2008 眼科植入物.眼内晶状体.第4部分:标注和信息

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information

ISO 12866:1999/Amd 1:2008 眼科器械.视野计.修改件1

Ophthalmic instruments - Perimeters; Amendment 1

YY 0673-2008 眼科仪器.验光仪

本标准规定了验光仪的要求和试验方法。

Opthalmic instruments.Eye refractometers