11.040.70 眼科设备 标准查询与下载
共找到 1849 条与 眼科设备 相关的标准，共 124 页
BS EN ISO 12870. Ophthalmic optics. Spectacle frames. Requirements and test methods
- ICS
- 11.040.70
- CCS
- 发布
- 2022-01-25
- 实施
- 2022-01-25
本文件规定了开展视力健康检查的术语和定义、要求、检查流程、数据记录与结果反馈、质量控制与效果评价。
Vision health examination technical service specification
- ICS
- 11.040.70
- CCS
- Q849
- 发布
- 2022-01-24
- 实施
- 2022-01-24
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
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- 11.040.70
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- 发布
- 2022-01-17
- 实施
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
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- 11.040.70
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- 发布
- 2022-01-17
- 实施
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
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- 11.040.70
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- 发布
- 2021-12-28
- 实施
Ophthalmic implants — Intraocular lenses —Part 6: Shelf-life and transport stability testing
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- 11.040.70
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- 发布
- 2021-12-28
- 实施
Ophthalmic implants — Intraocular lenses —Part 5: Biocompatibility
- ICS
- 11.040.70
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- 发布
- 2021-12-28
- 实施
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
- ICS
- 11.040.70
- CCS
- 发布
- 2021-12-28
- 实施
Ophthalmic implants — Intraocular lenses —Part 2: Optical properties and test methods
- ICS
- 11.040.70
- CCS
- 发布
- 2021-12-28
- 实施
Ophthalmic implants — Intraocular lenses —Part 5: Biocompatibility
- ICS
- 11.040.70
- CCS
- 发布
- 2021-12-28
- 实施
Ophthalmic implants — Intraocular lenses —Part 6: Shelf-life and transport stability testing
- ICS
- 11.040.70
- CCS
- 发布
- 2021-12-28
- 实施
Ophthalmic implants — Intraocular lenses —Part 2: Optical properties and test methods
- ICS
- 11.040.70
- CCS
- 发布
- 2021-12-28
- 实施
Ophthalmic optics－Spectacle frames－Requirements and test methods
- ICS
- 11.040.70
- CCS
- 发布
- 20211208
- 实施
- 20211208
Optics and optical instruments－Ophthalmic optics－Formers
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- 11.040.70
- CCS
- 发布
- 20211208
- 实施
- 20211208
Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations
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- 11.040.70
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- 发布
- 20211208
- 实施
- 20211208
Ophthalmic implants－Ocular endotamponades
- ICS
- 11.040.70
- CCS
- 发布
- 20211208
- 实施
- 20211208
Ophthalmic optics－Visual acuity testing－Standard optotype and its presentation
- ICS
- 11.040.70
- CCS
- 发布
- 20211208
- 实施
- 20211208
