11.040.70 眼科设备 标准查询与下载

YY/T 0719.10-2022 眼科光学 接触镜护理产品 第10部分：保湿润滑剂测定方法

本文件规定了接触镜护理产品中保湿润滑剂（羟丙基甲基纤维素和聚乙烯吡咯烷酮）含量的测定方法。本文件适用于含保湿润滑剂（羟丙基甲基纤维素和/或聚乙烯吡咯烷酮）的接触镜护理产品。

Ophthalmic optical contact lens care products Part 10: Method for determination of moisturizing lubricants

YY/T 0633-2022 眼科仪器 间接检眼镜

本文件规定了用于观察眼底间接像的手持式、眼镜式、头戴式间接检眼镜的最低要求和试验方法。本文件适用于手持式、眼镜式、头戴式间接检眼镜。本文件不适用于间接检眼镜用的聚光镜和附件。本文件不适用于台面固定式的仪器，也不适用于主要用于图像捕捉和/或图像处理的检眼镜，如采用扫描激光技术的检眼镜。

Ophthalmic Instrument Indirect Ophthalmoscope

YY 1289-2022 激光治疗设备 眼科激光光凝仪

本文件规定了眼科激光光凝仪的术语和定义、产品组成、要求、试验方法等内容。本文件适用于临床上进行眼底激光光凝治疗的设备。

Laser treatment equipment Ophthalmic laser photocoagulation device

YY 0719.2-2022 眼科光学 接触镜护理产品 第2部分：基本要求

本文件规定了接触镜护理产品的安全和性能要求。

Ophthalmic optical contact lens care products Part 2: Basic requirements

T/COOA 4-2022 定制太阳镜和太阳镜片

本文件规定了定制太阳镜和太阳镜片的定义、要求、试验方法、标志、包装、运输和储存。 本文件适用于一般用途的定制太阳镜和太阳镜片，包括基片着色和膜层着色的太阳镜片。 本文件不适用于防护人造光源（如日光浴室使用的光源）辐射的镜片和用于工业用途的护目镜，也不适用于可直接观测太阳（如观测日蚀等）的特殊镜片。

Custom Sunglasses and Sunglasses

T/COOA 5-2022 蓝光防护成镜和镜片

本文件规定了蓝光防护成镜和蓝光防护镜片的术语和定义、要求、试验方法、标志等。  本文件适用于光透射比大于80％（0类）的蓝光防护成镜和蓝光防护镜片。

Blue Light Protective Mirrors and Lenses

22/30435087 DC BS EN 80601-2-58 医疗电气设备 第 2-58 部分 眼科手术用晶状体摘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

BS EN 80601-2-58. 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

BS EN ISO 10942:2022 眼科仪器 直接检眼镜

1   Scope This document, together with ISO 15004‑1 and ISO 15004‑2, specifies minimum requirements and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus. This document takes precedence over ISO 15004‑1 and ISO 15004‑2, if differences exist.

Ophthalmic instruments. Direct ophthalmoscopes

BS EN ISO 15798:2022 眼科植入物 眼科粘稠手术装置

1   Scope This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices 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 intraocular tissues and to manipulate tissues during surgery. This document 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

BS EN ISO 8980-3:2022 眼科光学 未切割的成品眼镜片 透过率规格及测试方法

1   Scope This document specifies requirements for the transmittance properties of uncut and unmounted finished spectacle lenses, including attenuation of solar radiation. This document is not applicable to — spectacle lenses having specific transmittance or absorption characteristics prescribed for medical reasons, — products to which specific personal protective equipment transmittance standards apply, and — products intended for direct observation of the sun, such as for solar-eclipse viewing. NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles. NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980‑1 and ISO 8980‑2, and for mounted lenses, in ISO 21987.

Ophthalmic optics. Uncut finished spectacle lenses. Transmittance specifications and test methods

EN ISO 8980-3:2022 眼科光学.未切边成品眼镜片.第3部分:透光性规范和试验方法

This document specifies requirements for the transmittance properties of uncut and unmounted finished spectacle lenses, including attenuation of solar radiation. This document is not applicable to — spectacle lenses having specific transmittance or absorption characteristics prescribed for medical reasons, — products to which specific personal protective equipment transmittance standards apply, and — products intended for direct observation of the sun, such as for solar-eclipse viewing. NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles. NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980‑1 and ISO 8980‑2, and for mounted lenses, in ISO 21987.

Ophthalmic optics - Uncut finished spectacle lenses - Part 3: Transmittance specifications and test methods (ISO 8980-3:2022)

YY/T 0634-2022 眼科仪器 眼底照相机

Ophthalmic instrument fundus camera

ISO 8980-3:2022 眼科光学.未切割成品眼镜镜片.第3部分:透射率规范和试验方法

This document specifies requirements for the transmittance properties of uncut and unmounted finished spectacle lenses, including attenuation of solar radiation. This document is not applicable to — spectacle lenses having specific transmittance or absorption characteristics prescribed for medical reasons, — products to which specific personal protective equipment transmittance standards apply, and — products intended for direct observation of the sun, such as for solar-eclipse viewing. NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles. NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980-1

Ophthalmic optics — Uncut finished spectacle lenses — Part 3: Transmittance specifications and test methods

22/30406184 DC BS EN ISO 9342-1 光学和光学仪器 用于焦度计校准的测试镜片 第 1 部分：用于测量眼镜镜片的焦度计的参考镜片

BS EN ISO 9342-1. Optics and optical instruments. Test lenses for calibration of focimeters - Part 1. Reference lenses for focimeters used for measuring spectacle lenses

YY/T 0719.5-2022 眼科光学 接触镜护理产品 第5部分：接触镜与接触镜护理产品物理相容性的测定

Ophthalmic Optical Contact Lens Care Products Part 5: Determination of Physical Compatibility of Contact Lenses and Contact Lens Care Products

YY 9706.258-2022 医用电气设备 第2-58部分：眼科手术用晶状体摘除及玻璃体切除设备的基本安全和基本性能专用要求

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

YY/T 0871-2022 眼科光学 接触镜 多患者试戴接触镜的卫生处理

Hygienic handling of ophthalmic optical contact lenses when multiple patients try on contact lenses

GSO ISO 11979-2:2022 眼科植入物 人工晶状体 第2部分：光学性能和测试方法

ISO 11979-2:2014 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor ?IOL' used throughout ISO 11979-2:2014 also includes phakic intraocular lenses (PIOL).

Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods

EN ISO 15798:2022 眼科植入物.眼科手术粘接器件

This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices 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 intraocular tissues and to manipulate tissues during surgery. This document 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 (ISO 15798:2022)

EN ISO 10942:2022 眼科仪器.直接检眼镜

This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus. This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)