C32 眼科与耳鼻咽喉科手术器械 标准查询与下载

YY/T 0189-2008 鼻镜

本标准规定了鼻镜的分类与型式、要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存。 本标准适用于检查用鼻镜和手术用鼻镜。检查鼻镜供鼻腔检查用，手术鼻镜供鼻腔及鼻甲作检查及手术用。

Nasal specula

KS P 8418-2008 氧气发生器型闭合呼吸器

이 표준은 광산, 공장 등의 사업장, 재해 현장, 선박, 기타에 있어서 산소 결핍 공기 또

Oxygen-generating closed-circuit breathing apparatus

BS EN ISO 24157:2008 眼科光学器件和仪器.人眼的失常报告

Ophthalmic optics and instruments - Reporting of aberrations of the human eye

ISO 24157:2008 眼科光学器件和仪器.人眼的失常报告

This International Standard specifies standardized methods for reporting aberrations of the human eye.

Ophthalmic optics and instruments - Reporting aberrations of the human eye

BS 8497-1:2008 遮掩和医疗设施用人类和动物防强光源的防目镜.产品规范

This British Standard specifies performance, test methods and labelling of eye protectors used for ILS equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 180 nm to 3 000 nm, with the exception of laser radiation. This standard is not applicable to eye protectors for use with tanning equipment, ophthalmic instruments or other medical/cosmetic devices, the safety issues of which are addressed through other European and British standards.

Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications – Part 1: Specification for products

BS 8497-2:2008 遮掩和医疗设施用人类和动物防强光源的防目镜.使用指南

This British Standard gives guidance and information to users, manufacturers and suppliers of ILS devices and safety advisors on the selection and safe use of eye protectors for humans and animals for cosmetic and medical applications used against excessive exposure to optical radiation in the spectral range 180 nm to 3 000 nm, with the exception of laser radiation. This standard is not applicable to eye protectors for use with tanning equipment, ophthalmic instruments or other medical/cosmetic devices, the safety issues of which are addressed through other European and British standards.

Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 2: Guidance on use

GOST R 53078-2008 眼科植入物.粘弹性眼科植入物装置.一般安全要求

Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements

ANSI/AAMI/IEC 80601-2-58:2008 医疗电气设备.第2-58部分:眼外科用晶状体移除装置和玻璃体切除装置基本安全性及重要性能的详细要求

Applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment.

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

ANSI Z80.23-2008 眼科学.角膜形状体系.标准术语.要求

This standard applies to instruments, systems and methods that are intended to measure the shape of the cornea of the human eye over a majority of its anterior surface. Terms peculiar to the characterization of corneal shape are defined. Minimum requirements for instruments and systems classified as corneal topographers are outlined. Tests and procedures that verify that a system or instrument complies with the standard and thereby qualifies as a corneal topographer per this standard are described.

Opthalmics - Corneal Topography Systems - Standard Terminology - Requirements

DIN EN ISO 11979-6:2007 眼科植入物.眼内透镜.第6部分:保存期限和运输稳定性

This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses(IOLs)in their final packagong can be determined.These tests include procedures to establish the stability of IOLs in distribution and storage.

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007); English version of DIN EN ISO 11979-6:2007-11

KS P 8405-2007 医用踏旋器

이 규격은 운동 부하 검사 및 의학적 재활용의 전기 동력을 이용한 트레드밀에 대해서 규정한

Medical treadmils

BS EN ISO 11979-6:2007 眼科植入物.眼内透镜.贮藏寿命和运输稳定性

ISO 11979-6:2007 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.

Ophthalmic implants. Intraocular lenses. Shelf-life and transport stability

NF S94-750-6:2007 眼科植入物.眼内晶状体.第6部分:储存期限和运输稳定性

Ophthalmic implants - Intraocular lenses - Part 6 : shelf-life and transport stability.

NF S12-300-1:2007 眼科设备.基本要求和试验方法.第1部分:全部眼科设备用一般要求

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

ANSI Z80.11-2007 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.

Laser Systems for Corneal Reshaping

ISO/TS 24348:2007 眼科光学.眼镜架.从金属和合成眼镜架中释放镍的磨损和探测模拟法

This Technical Specification specifies methods for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated metal and combination spectacle frames, and for detecting the release of nickel from those parts of metal and combination spectacle frames, whether coated or not, intended to come into direct and prolonged contact with the skin, in order to determine whether such parts release nickel at a rate greater than 0,5 ?g/cm2/week. This Technical Specification aims to control those spectacle frames that, if produced with materials and/or surface treatments containing nickel, can be worn by nickel-sensitized persons.

Ophthalmic optics - Spectacle frames - Method for the simulation of wear and detection of nickel release from metal and combination spectacle frames

ISO 11979-6:2007 眼科植入物.眼内透镜.第6部分:保存期限和运输稳定性

This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses(IOLs)in their final packaging can be determined .These tests include procedures to establish the stability of IOLs in distribution and storage.

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability

ISO/TR 20824:2007 眼科仪器.眼科仪器标准中的光用背景危害规范

The purpose of this Technical Report is to provide detailed information on the rationale behind the limit values and the requirements of ISO 15004-2[52]. The specifications in ISO 15004-2 are substantially revised from those in ISO 15004:1997[50].

Ophthalmic instruments - Background for light hazard specification in ophthalmic instrument standards

BS EN ISO 15004-2:2007 眼科仪器.基本要求和试验方法.光危害防护

ISO 15004-2:2007 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye. ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye. ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.

Ophthalmic instruments - Fundamental requirements and test methods - Light hazard protection

DIN EN ISO 15004-2:2007 眼科仪器.基本要求和试验方法.第2部分:光危害防护

This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all oophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within theirrespective International Standards,i.e.all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic insruments that direct optical radiation into or at the eye. Where differences exist between this part of ISO 15004 and the light hazard requirements section of the respective vertical International Standard,then the vertical Intertional Standard shall take precedence. NOTE The emission limits are based on the Internaiional Commission on Non-lonizing Radiation Protection(ICNIRP)guidelines for human exposure to optical radiation.See Bibiliography. This part of ISO 15004 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended ofr treatment of the eye. This part of ISO 15004 classifies ophthalmic instruments into either Group 1 or Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007);English version of DIN EN ISO 15004-2:2007-06