C32 眼科与耳鼻咽喉科手术器械 标准查询与下载

BS EN ISO 10939:2007 眼科仪器.缝灯显微镜

ISO 10939:2007, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. ISO 10939:2007 is not applicable to microscope accessories, e.g. photographic equipment and lasers. ISO 10939:2007 takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Ophthalmic instruments - Slit-lamp microscopes

NF S12-300-2*NF 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

Ophthalmic instruments - Fundamental requirements and test methods - Part 2 : light hazard protection.

ANSI Z80.24-2007 眼科光学.眼科光学设备的信息交换

A communication protocol for equipment and computers used for processing of prescription eyeware.

Opthalmic Optics - Information Interchange for Ophthalmic Optical Equipment

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 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, i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic instruments 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 International Standard shall take precedence. This part of ISO 15004 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for 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

KS P ISO 11979-6:2006 眼科植入物.眼内晶状体.第6部分:保存期限和运输稳定性

이 규격은 최종 용기에 담긴 무균 상태의 인공 수정체(IOL)의 보관 기간을 측정하는 검사

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

KS P ISO 16671:2006 眼科植入物.眼外科用冲洗法

이 규격은 의도한 수행, 설계 속성, 예비 임상학적 그리고 임상학적 평가, 멸균, 제품 포

Ophthalmic implants－Irrigating solutions for ophthalmic surgery

KS P ISO 15798:2006 眼科植入物.眼科手术粘接器件

적용 범위 이 규격은 안과적 점탄 수술 기구(OVD)에 대하여 규정한다. OVD는 점성 그

Ophthalmic implants－Ophthalmic viscosurgical devices

KS P ISO 15752:2006 眼科仪器.内发光器.光辐射安全的基本要求和试验方法

이 규격은 안 수술 중 눈 속을 조명하는 데 사용되는 눈속 조명기의 광 방사 안전 측면에

Ophthalmic instruments－Endoilluminators－Fundamentalrequirements and test methods for optical radiation safety

KS P ISO 11979-5:2006 眼科植入物.眼内晶状体.第5部分:生物相容性

이 규격은 KS P ISO 10993의 관련 부분들에 개요가 소개된 요구 사항을 항목에 추

Ophthalmic implants－Intraocular lenses－Part 5：Biocompatibility

KS P ISO 11979-7:2006 眼科植入物.眼内晶状体.第7部分:临床检测

이 규격은 무수정체안(無水晶體眼) 교정을 위한 후방 단초점 인공 수정체와 전방 단초점인

Ophthalmic implants－Intraocular lenses－Part 7：Clinical investigations

NF S94-750-10:2006 眼科植入物.眼底镜.第10部分:晶体眼人工晶体植入术(PHAKIC)眼底镜

Ophthalmic implants - Intraocular lenses - Part 10 : phakic intraocular lenses.

NF S94-750-9:2006 眼科植入物.眼底镜.第9部分:多点聚焦眼底镜

Ophthalmic implants - Intraocular lenses - Part 9 : multifocal intraocular lenses.

DIN EN ISO 11979-9:2006 眼科植入物.眼内透镜.第9部分:多点聚焦眼内透镜

This part of ISO 11979 is applicable to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near). NOTE The term "near vision" as used in this part of ISO 11979 includes useful vision at a distance of claimed benefit; e.g. near and/or intermediate distances.

Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006); English version of DIN EN ISO 11979-9:2006-12

DIN 58275:2006 医疗器械.睑板腺囊肿镊子

The project defines dimensions and marking of chalazion forceps, as used in surgery, public health service or armed forces.

Medical instruments - Chalazion forceps

DIN 58281-1:2006 医疗器械.第1部分:不镶硬质合金的斜视用剪刀

The project defines dimensions and marking of strabismus scissors without carbide inserts, as used in surgery, public health service or armed forces.

Medical instruments - Part 1: Strabismus scissors without carbide inserts

JIS T 7313:2006 眼科光学.未切边成品眼镜片.单视镜片

この規格は，屈折補正に使用するアンカットフイニッシュト単焦点眼鏡レンズ(以下，レンズという。)の光学的特性及び幾何学的特性について規定する。

Ophthalmic optics -- Uncut finished spectacle lenses -- Single-vision lenses

JIS T 7314:2006 眼科光学.未切边成品眼镜片.多焦镜片

この規格は，屈折補正に使用するアンカットフイニッシュト多焦点眼鏡レンズ(以下，レンズという。)の光学的特性及び幾何学的特性について規定する。

Ophthalmic optics -- Uncut finished spectacle lenses -- Multifocal lenses

JIS T 7315:2006 眼科光学.未切边成品眼镜片.渐变焦眼镜片

この規格は，屈折補正に使用するアンカットフィニッシュト累進屈折力眼鏡レンズ(以下，レソズという。)の光学的特性及び幾何学的特性について規定する。

Ophthalmic optics -- Uncut finished spectacle lenses --Progressive power lenses

JIS T 7331:2006 眼科光学.眼镜镜片.未切精加工眼镜片的基本要求

この規格は，屈折補正に使用するアンカットフィニッシュト眼鏡レンズ(以下，レンズという。)の基本的要求事項について規定する。

Ophthalmic optics -- Spectacle lenses -- Fundamental requirements for uncut finished lenses

NF S94-750-1:2006 眼科植入物.眼内镜片.第1部分:词汇

Ophtalmic implants - Intraocular lenses - Part 1 : vocabulary.