11.040.70 眼科设备 标准查询与下载

GSO ISO 15254:2015 光学和光学设备 增强低视力的电光设备

This International Standard applies to electro-optical devices specified by the manufacturer for use by visually impaired persons, as low-vision aids. It specifies electro-optical and mechanical requirements and test methods. This International Standard does not cover optical devices for enhancing low vision which are specified in ISO 15253.

Ophthalmic optics and instruments -- Electro-optical devices for enhancing low vision

GSO ISO 14889:2015 眼科光学 眼镜镜片 未切割成品镜片的基本要求

This International Standard specifies fundamental requirements for uncut finished spectacle lenses. This International Standard is not applicable to protective spectacle lenses. This International Standard takes precedence over the corresponding requirements of other standards, if differences exist.

Ophthalmic optics -- Spectacle lenses -- Fundamental requirements for uncut finished lenses

GSO ISO 16672:2015 眼部植入物 眼内塞

This International Standard applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of OEs, this International Standard 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

GSO ISO 12867:2015 眼科设备 实验框架

This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for trial frames for holding trial case lenses, complying with ISO 9801, in front of a subject's eyes in order to assess visual acuity and facilitate optical correction of vision. This International Standard is applicable to lens holders mounted on headbands, bracket-mounted frames and frames mounted in the manner of spectacles with supports on the ears and the bridge of the nose. It is applicable to all types of trial frame, including half-eye and rotating lens holders. This International Standard is not applicable to refractor heads (see ISO 10341). This International Standard takes precedence over ISO 15004-1, if differences exist.

Ophthalmic instruments -- Trial frames

GSO ISO 11986:2015 眼科光学 隐形眼镜和隐形眼镜护理产品 防腐剂吸收和释放的测定

This International Standard provides general procedures for the selection of methods, preparation of samples, and conduct of testing for the uptake and release of preservatives from contact lenses. NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses. NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This International Standard does not measure disinfection performance.

Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of preservative uptake and release

GSO ISO 12870:2015 眼科光学 眼镜架 要求和测试方法

This International Standard specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses. It is applicable to frames at the point of sale by the manufacturer or supplier to the retailer. This International Standard is applicable to all spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames. It is also applicable to spectacle frames made from natural organic materials. NOTE See Annex A for recommendations on the design of spectacle frames. This International Standard is not applicable to complete custom-made spectacle frames or to products designed specifically to provide personal eye protection.

Ophthalmic optics -- Spectacle frames -- Requirements and test methods

GSO ISO 11987:2015 眼科光学 隐形眼镜 保质期的测定

This International Standard specifies test procedures for determining the stability of contact lenses once they are placed in their final packaging during storage and distribution. NOTE The results obtained can be used for determining the expiry date.

Ophthalmic optics -- Contact lenses -- Determination of shelf-life

EN ISO 12312-1:2013/A1:2015 眼睛和脸部防护.太阳镜和相关眼镜.第1部分:太阳镜的一般用途(ISO 12312.1:2013/Amd 1:2015)

Eye and face protection - Sunglasses and related eyewear - Part 1: Sunglasses for general use (ISO 12312-1:2013/Amd 1:2015)

DIN EN ISO 11979-8:2015 眼科植入物.人工晶体.第8部分:基本要求(ISO 11979-8-2006+Amd.1-2011);德文版本EN ISO 11979-8-2015

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2015

BS EN ISO 16672:2015 眼科植入物.眼内填塞

Ophthalmic implants. Ocular endotamponades

BS EN ISO 16671:2015 眼科植入物.眼外科冲洗法

Ophthalmic implants. Irrigating solutions for ophthalmic surgery

EN ISO 16671:2015 眼科植入物.眼外手术用冲洗溶液（ISO 16671:2015）

Mit Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, präklinische und klinische Bewertungen, Sterilisation, Verpackung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller fest. Diese Internationale Norm gilt für ophthalmische Spüllösungen (OIS, en: ophthalmic irrigating solution), die in der ophthalmologischen Chirurgie zum Einsatz kommen. Diese Spüllösungen weisen keine primär immunologische, pharmakologische oder metabolische Funktion auf.

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)

EN ISO 16672:2015 眼科植入物.眼内填塞 (ISO 16672:2015)

Diese Internationale Norm gilt für okulare Endotamponaden (OE), einer Klasse nicht-solider Implantate, die in der Ophthalmologie zur Glättung und zum Anlegen einer abgelösten Netzhaut an die Aderhaut oder als Netzhauttamponade verwendet werden. Mit Bezug auf die Sicherheit und Effektivität von OE legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, präklinische und klinische Bewertung, Sterilisation, Verpackung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller fest.

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

ISO 16671:2015 眼科植入物.眼外科用冲洗法

This International Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. This International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

Ophthalmic implants - Irrigating solutions for ophthalmic surgery

DIN EN ISO 14534:2015 眼科光学.隐形眼镜和隐形眼镜护理产品.基本要求(ISO 14534-2011);德文版本EN ISO 14534-2015

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015

ISO 16672:2015 外科植入物.眼内填塞

Ophthalmic implants - Ocular endotamponades

ISO 8624:2011/Amd 1:2015 眼科光学.眼镜架.测量系统与术语;修改件1

Ophthalmic optics - Spectacle frames - Measuring system and terminology; Amendment 1

BS EN 80601-2-58:2015 医疗电气设备.眼科手术用晶状体移除装置和玻璃体切除装置基本安全和基本性能的特殊要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

EN ISO 12312-2:2015 眼睛和脸部防护.太阳镜和相关眼镜.第2部分:直视太阳的滤光片(ISO 12312.2:2015)

Dieser Teil der ISO 12312 gilt für alle Produkte ohne Korrekturwirkung (mit Nullgläsern), die für die direkte Beobachtung der Sonne vorgesehen sind, zum Beispiel bei der Betrachtung einer Sonnenfinsternis. Informationen zur Verwendung von Filtern für die direkte Beobachtung der Sonne werden in Anhang A und Anhang B gegeben. Dieser Teil der ISO 12312 gilt nicht für: a) Sonnenbrillen ohne Korrekturwirkung (mit Nullgläsern) sowie Aufsteckscheiben für den allgemeinen Gebrauch bestimmt zum Schutz gegen Sonnenstrahlung; b) Augenschutz gegen die Strahlung künstlicher Lichtquellen, z. B. von Solarien; c) Augenschutzgeräte speziell für den Sport (z. B. Skibrillen oder andere Arten); d) Sonnenbrillen, die aus medizinischen Gründen zur Dämpfung von Sonnenstrahlung verschrieben wurden; e) Sonnenfilter mit Korrekturwirkung.

Eye and face protection - Sunglasses and related eyewear - Part 2: Filters for direct observation of the sun (ISO 12312-2:2015)

EN 80601-2-58:2015 医用电气设备 第 2-58 部分：眼科手术用晶状体摘除装置和玻璃体切除装置的基本安全和基本性能的特殊要求

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