共找到 1851 条与 眼科设备 相关的标准,共 124 页
IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.
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
Ophthalmics – Accommodative Intraocular Lenses
Ophthalmic optics. Contact lens care products. Method for evaluating Acanthamoeba encystment by contact lens care products
This International Standard is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye. This International Standard defines certain terms that are specific to this diagnostic procedure. This International Standard specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with this International Standard and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs. NOTE It is anticipated that this International Standard can, in a future revision, be expanded to include all segments of the human eye.
Ophthalmic instruments - Optical coherence tomograph for the posterior segment of the human eye
Ophthalmic optics - Contact lens care products - Method for evaluating Acanthamoeba encystment by contact lens care products
Ophthalmic implants. Intraocular lenses. Fundamental requirements
Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014); German version EN ISO 14730:2014
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2014); German version EN ISO 11978:2014
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014); German version EN ISO 11979-6:2014
Optics and optical instruments - Focimeters - Part 1: General purpose instruments (ISO 8598-1:2014)
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 (Second Edition)
Optics and optical instruments - Focimeters - Part 1: General purpose instruments (ISO 8598-1:2014); German version EN ISO 8598-1:2014
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
Ophthalmic instruments. Fundus cameras. Technical requirements. Methods for control of optical characteristics
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