11.040.70 眼科设备 标准查询与下载

ABNT NBR ISO 10685-1:2020 眼科光学 - 眼镜架和太阳镜电子目录和识别第1部分：产品标识和电子目录产品层次结构

Ophthalmic optics - Spectacle frames and sunglasses electronic catalogue and identification Part 1: Product identification and electronic catalogue product hierarchy

ABNT NBR ISO 13212:2020 眼科光学 - 隐形眼镜护理产品 - 保质期使用指南

Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life

BS EN ISO 15004-1:2020 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

Ophthalmic instruments. Fundamental requirements and test methods. General requirements applicable to all ophthalmic instruments

KS B ISO 11978-2020 眼科光学 隐形眼镜和隐形眼镜护理产品 制造商提供的信息

Ophthalmic optics－Contact lenses and contact lens care products－Information supplied by the manufacturer

KS B ISO 14534-2020 眼科光学 隐形眼镜及隐形眼镜护理产品 基本要求

Ophthalmic optics－Contact lenses and contact lens care products－Fundamental requirements

KS B ISO 13212-2020 眼科光学 隐形眼镜护理产品 保质期测定指南

Ophthalmic optics－Contact lens care products－Guidelines for determination of shelf-life

NF S12-300-1*NF EN ISO 15004-1:2020 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

Le présent document spécifie les exigences fondamentales s'appliquant aux instruments ophtalmiques non invasifs, actifs et non actifs, et aux dispositifs pour malvoyants. Il est également applicable aux tonomètres, mais ne s'applique pas aux autres instruments ophtalmiques utilis

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

OENORM EN ISO 8624:2020 眼科光学 眼镜架 测量系统和词汇（ISO 8624:2020）

Ophthalmic optics - Spectacle frames - Measuring system and vocabulary (ISO 8624:2020)

T/ZZB 1830-2020 眼镜镜片 光致变色光学树脂镜片

本文件规定了光致变色光学树脂镜片的术语和定义、分类、基本要求、技术要求、试验方法、检验规则、标志、包装、运输和贮存及质量承诺。 本文件适用于具有光致变色光学性能的高分子材料制成的眼镜镜片。

Uncut finished spectacle lenses- Photochromic optical hard resin lenses

OENORM EN ISO 15253:2020 眼科光学和仪器 用于增强低视力的光学和电光设备（ISO/DIS 15253:2020）

Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO/DIS 15253:2020)

EN ISO 15004-1:2020 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

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)

BS EN ISO 11979-5:2020 眼科植入物 人工晶状体 生物相容性

What is ISO 11979 ‑ 5 about?    ISO 11979 discusses intraocular lenses for ophthalmic implants. ISO 11979 ‑ 5 outlines requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include the evaluation of physicochemical properties that are relevant to biocompatibility.   ISO 11979 also gives guidance on conducting an ocular implantation test.   Who is ISO 11979 ‑ 5 for?   ISO 11979 ‑ 5 on the biocompatibility of intraocular lenses is useful for:  

Ophthalmic implants. Intraocular lenses - Biocompatibility

BS EN ISO 11978:2017+A1:2020 眼科光学 隐形眼镜和隐形眼镜护理产品 标签

What is ISO 11978+A1 about?    ISO 11978+A1 discusses ophthalmic optics labelling with reference to contact lenses and contact lens care products. ISO 11978+A1 specifies the information to be provided by the manufacturer of contact lenses and contact lens care products, to ensure the correct and safe use of these devices and their accessories. The information provided by the manufacturer is useful for both types of users of contact lenses: the eye care professional and the contact lens wearer.   ISO 11978+A1 provides a suitable framework for developing labelling for contact lenses and contact lens care products. Conformance to the elements herein is intended to be sufficient for developing appropriate labelling for countries without existing laws or regulations for medical device labelling.   Note: ISO 11978+A1 does not specify the format in which such information shall be provided.  ...

Ophthalmic optics. Contact lenses and contact lens care products. Labelling

T/COOA 002-2020 儿童定配眼镜

    本标准适用于儿童单光及多焦点配装眼镜，主要技术指标：材料、表面质量、镜片厚度、镜片的光学要求（顶焦度、柱镜轴位方向、光学中心水平距离等）、透射比性能、镜架要求（外观质量、镀层性能（包覆层性能）、阻燃性、镍析出量等）、装配质量。其中镜片的光学参数、透射比性能中的紫外要求、抗冲击性能比成人配装眼镜要求有提高，镍析出量在配装眼镜标准中是首次提出。

Children's custom glasses

T/COOA 001-2020 儿童眼镜架

结构与材料、尺寸、高温尺寸稳定性、机械强度、包覆层性能、阻燃性、镍析出量。

children's spectacle frame

T/COOA 003-2020 儿童太阳镜

    本标准着重规定儿童太阳镜和太阳镜片的透射比要求；光学参数严于成人太阳镜的要求；具有防护紫外线功能；规定镍析出量要求；水平中心距离定为54 mm（不同于成人的62 mm）；镜片应使用能防冲击镜片，符合落球试验的要求。

children's sunglasses

DS/EN ISO 11978:2020 眼科光学器件“隐形眼镜和隐形眼镜护理产品”标签“修正案 1（ISO 11978:2017/Amd 1:2020）

Ophthalmic optics – Contact lenses and contact lens care products – Labelling – Amendment 1 (ISO 11978:2017/Amd 1:2020)

EN ISO 11978:2017/A1:2020 眼科光学. 接触镜片和接触镜片护理产品. 标记 包含修改件A1,2020

Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)

EN ISO 11979-5:2020 眼科植入物.眼内透镜.第5部分:生物相容性

This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

ISO 11978:2017/Amd 1:2020 眼科光学.接触镜和接触镜护理产品.标签.修改件1

Ophthalmic optics — Contact lenses and contact lens care products — Labelling — Amendment 1