眼科设备标准-分析测试百科网

DB37/T 4166-2020 防蓝光眼镜片及相关眼镜产品蓝光透射比要求和试验方法

Requirements and test methods for blue light transmittance of anti-blue light glasses lenses and related eyewear products

ICS: 11.040.70
CCS: Y 89
发布: 2020-09-30
实施: 2020-10-30

ISO 11979-5:2020 眼科植入物 - 眼内镜片 - 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

ICS: 11.040.70
CCS
发布: 2020-09-24
实施: 0000-00-00

T/LZZLXH 038-2020 配装眼镜质量技术指南

4　基本要求 4.1　企业资质与产品标识 4.1.1　从事眼镜验配服务的企业应取得并明示营业执照，依法取证、合法经营。 4.1.2　降水量产品信息标识真实有效。每副定配眼镜产品应标明产品名称、生产单位名称、地址、产品执行的标准及产品质量检验合格证明、生产日期。每副定配眼镜应标明顶焦度值、轴位、光学中心水平距离等参数。 4.2　眼镜验配技术和产品质量符合相关法律法规和标准的要求。 5　人员要求 5.1　营业员 a)应具备符合工作岗位要求的专业技能和专业知识，熟悉相关标准。 b)应取得初级以上（含初级）验光员国家职业资格证书或初级以上（含初级）定配工国家职业资格证书。 5.2　验光员 a)应具备符合工作岗位要求的专业技能和专业知识，能熟练操作各种验光设备，熟悉定配眼镜相关标准要求。 b)应取得中级（国家职业资格四级）或以上验光员国家职业资格证书。 5.3　定配工 a)应具备符合工作岗位要求的专业技能和专业知识，熟悉定配眼镜相关标准要求。 b)应取得中级或以上定配工国家职业资格证书。 c)能熟练操作各种加工设备，准确理解验光人员开具的处方单、加工单、加工设备明书等技术文件。 5.4　检验人员 a)应具备符合工作岗位要求的专业技能和专业知识，能熟练操作检测设备，熟悉与定配眼镜产品检测相关的规定和标准要求，能正确判断加工完成后的产品质量状况。 b)应参加相关质量监督部门组织的专业培训，经考试合格后上岗。 5.5　技术和质量负责人员 a)具有大专及以上学历，熟悉国家相关政策法规，具有与质量、眼镜专业技术管理相适应的专业技能和专业知识，了解和熟悉眼镜产品相关标准，应熟悉相关法律法规。 b)应取得中级以上（含中级）验光员国家职业资格证书或中级以上（含中级）定配工国家职业资格证书。 5.6　店（柜）负责人 a)具有大专及以上学历，熟悉眼镜相关政策法规和标准要求，掌握经营管理、营销服务管理、质量管理及异常情况处理等基本知识和专业技能。 b)应取得中级以上（含中级）验光员国家职业资格证书或中级以上（含中级）定配工国家职业资格证书。 6　人员要求应建立仪器设备管理制度，建立设备台账，制定仪器设备检定校准、维护保养计划，严格按计划执行并做相应记录。属于国家强检的设备应依法定期强检，并明示有效的强检标志，确保设备均能有效运转。不得使用未经检定、超过检定周期或者经检定不合格的计量器具。 6.1　验光设备应具备焦度计、经检定合格的镜片箱、检影镜或经检定合格的电脑验光仪、瞳距仪或瞳距尺、试镜架、远用视力表灯箱或投影视力表、近用视力表以及阅读灯。 6.2　加工设备应具备焦度计、模板机、定中心仪、磨边机、倒边机、打孔机、开槽机、烘热器、抛光机和调整钳等整形工具。 6.3　检测设备应具备经检定合格的焦度计（分度值为0.01D）、0.5mm刻度不锈钢直尺和眼镜测量卡，加工场所还应具备测厚仪(精度要求0.1mm)和游标卡尺。 6.4　设备强检 a)属于国家强检的设备应依法定期强检，按规定登记造册并明示有效的强检标志。 b)不得使用未经检定、超过检定周期或者经检定不合格的计量器具。 6.5　设备维护应定期对验光设备、定配加工设备和检测设备进行维护保养，并做好记录。

Technical guide for the quality of assembled spectacles

ICS: 11.040.70
CCS: C404
发布: 2020-09-07
实施: 2020-09-07

BS EN ISO 8624:2020 眼科光学眼镜架测量系统和词汇

What is ISO 8624 about? ISO 8624 discusses spectacle frames for ophthalmic optics. ISO 8624 outlines a measuring system for spectacle frames and related vocabulary. It is applicable to spectacle frames with fronts that are intended to be symmetrical. The boxed lens system of measurement and definitions of spectacle frames are based on rectangular boxes that circumscribe the lens shapes. Who is ISO 8624 for?

Ophthalmic optics. Spectacle frames. Measuring system and vocabulary

ICS: 11.040.70
CCS
发布: 2020-07-31
实施: 2020-07-31

EN ISO 8624:2020 眼科光学.眼镜架.测量系统和术语

This document specifies a measuring system for spectacle frames and related vocabulary. It is applicable to spectacle frames with fronts that are intended to be symmetrical.

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

ICS: 11.040.70
CCS
发布: 2020-07-08
实施: 2020-10-31

YY/T 0719.6-2020 眼科光学接触镜护理产品第6部分：有效期测定指南

Ophthalmic optics—Contact lens care products—Part 6:Guidelines for determination of shelf-life

ICS: 11.040.70
CCS: C40
发布: 2020-06-30
实施: 2021-06-01

ISO 16672:2020 眼科植入物 - 眼内膜

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina. With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

Ophthalmic implants — Ocular endotamponades

ICS: 11.040.70
CCS
发布: 2020-06-26
实施

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

This document specifies a measuring system for spectacle frames and related vocabulary. It is applicable to spectacle frames with fronts that are intended to be symmetrical.

Ophthalmic optics — Spectacle frames — Measuring system and vocabulary

ICS: 11.040.70
CCS
发布: 2020-06-22
实施

ISO 15004-1:2020 眼科仪器 - 基本要求和测试方法 - 第1部分:适用于所有眼科仪器的一般要求

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. This document 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

ICS: 11.040.70
CCS
发布: 2020-06-04
实施

BS EN ISO 24157:2008+A1:2020 眼科光学和仪器报告人眼的像差

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

Ophthalmic optics and instruments. Reporting aberrations of the human eye

ICS: 11.040.70
CCS
发布: 2020-02-29
实施: 2020-02-29

BS EN ISO 8596:2018+A1:2020 眼科光学视力测试标准和临床视标及其表示

1 Scope This document specifies a range of Landolt ring optotypes and describes a method for measuring distance visual acuity under photopic conditions for the purposes of certification or licensing. This document is neither intended as a standard for clinical measurements nor for the certification of blindness or partial sight. Other optotypes used for clinical investigations are described in Annex A for information.

Ophthalmic optics. Visual acuity testing. Standard and clinical optotypes and their presentation