11.040.70 眼科设备 标准查询与下载
共找到 1850 条与 眼科设备 相关的标准，共 124 页
Ophthalmic instruments - Corneal topographers (ISO 19980:2021)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-06-00
- 实施
This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. This document is not applicable to ophthalmic instruments classified as ophthalmometers.
Ophthalmic instruments - Corneal topographers
- ICS
- 11.040.70
- CCS
- 发布
- 2021-06-00
- 实施
Ophthalmic instruments -- Fundamental requirements and test methods -- Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-05-10
- 实施
- 2021-05-10
This document specifies particular requirements for the biological evaluation of intraocular lenses, which apply in addition to the general requirements set forth in the horizontal standards for medical devices. The project further gives guidance on ocular implantation tests.
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020); German version EN ISO 11979-5:2020
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2021-05-01
- 实施
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. It is also applicable to low vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. The standard does
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020); German version EN ISO 15004-1:2020
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2021-05-00
- 实施
- 2021-05-01
本文件确定了偏振太阳镜的术语和定义、基本要求、技术要求、试验方法、检验规则、标志、包装、运输及贮存和质量承诺。 本文件适用于具有反射光过滤功能的偏振太阳镜。不适用于防人工光源辐射的护目镜及矫正视力用的眼镜。
Polarized sunglasses
- ICS
- 11.040.70
- CCS
- C358
- 发布
- 2021-04-24
- 实施
- 2021-05-27
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-04-15
- 实施
- 2021-04-15
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-04-15
- 实施
- 2021-04-15
Ophthalmic instruments - Direct ophthalmoscopes (ISO/DIS 10942:2021)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-04-15
- 实施
- 2021-04-15
Ophthalmic optics - Uncut finished spectacle lenses - Part 3: Transmittance specifications and test methods (ISO/DIS 8980-3:2021)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-04-01
- 实施
- 2021-04-01
The document specifies the information to be provided by the manufacturer with the product. This information is intented to ensure the correct and safe use of contact lenses and contact lens care products and is supplied to the practitioner to give to the wearer. Scope of amendme
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017 + Amd 1:2020); German version EN ISO 11978:2017 + A1:2020
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2021-04-00
- 实施
This standard applies to contrast vision testing under mesopic luminance conditions with and without glare in cases where requirements have been specified for purposes of road traffic or professional activities.
Visual acuity testing - Part 7: Mesopic contrast vision, without and with glare, for road traffic related vision testing; Text in German and English
- ICS
- 11.040.70
- CCS
- C05
- 发布
- 2021-04-00
- 实施
This document applies to visual acuity testing under daylight conditions as a prerequesite for issuing a driving licence.
Visual acuity testing - Part 6: Road traffic related vision screening test; Text in German and English
- ICS
- 11.040.70
- CCS
- C05
- 发布
- 2021-04-00
- 实施
This standard applies to visual acuity testing for use in expertise, e. g. for clinical measurements performed for certification of blindness or partial sight.
Visual acuity testing - Part 3: Test for use in expertise; Text in German and English
- ICS
- 11.040.70
- CCS
- C05
- 发布
- 2021-04-00
- 实施
this document applies for the vision acuity testing for use in expertise, e. g. for clinical measurements performed for certification of blindness or partial sight.
Visual acuity testing - Part 5: Vision screening test for general use; Text in German and English
- ICS
- 11.040.70
- CCS
- C05
- 发布
- 2021-04-00
- 实施
Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility (ISO 11979-5:2020)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-03-30
- 实施
- 2021-03-30
Ophthalmic optics -- Contact lenses and contact lens care products -- Labelling -- Amendment 1 (ISO 11978:2017/Amd 1:2020)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-03-30
- 实施
- 2021-03-30
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017 + Amd 1:2020) (consolidated version)
- ICS
- 11.040.70
- CCS
- 发布
- 2021-03-15
- 实施
- 2021-03-15
Ophthalmic optics and instruments - Reporting aberrations of the human eye
- ICS
- 11.040.70
- CCS
- 发布
- 2021-03-04
- 实施
- 2021-03-04
Ophthalmic optics - Spectacle frames - Measuring system and vocabulary
- ICS
- 11.040.70
- CCS
- 发布
- 2021-03-04
- 实施
- 2021-03-04
