C32 眼科与耳鼻咽喉科手术器械 标准查询与下载
共找到 553 条与 眼科与耳鼻咽喉科手术器械 相关的标准，共 37 页
La présente Norme internationale spécifie la méthode suivie pour évaluer l'activité de conservation antimicrobienne de tous les produits d'entretien des lentilles de contact conservés en emballages multidoses et fournit des lignes directrices sur les méthodes à utiliser pour la détermination de la durée d'utilisation après première ouverture, en annexes informatives.
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-12-05
- 实施
- 2014-12-05
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014); German version EN ISO 11979-7:2014
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-12
- 实施
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014); German version EN ISO 11979-2:2014
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-12
- 实施
Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006 + Amd.1:2014); German version EN ISO 11979-10:2006 + A1:2014
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-12
- 实施
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006 + Amd.1:2014); German version EN ISO 11979-9:2006 + A1:2014
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-12
- 实施
Ophthalmic implants. Intraocular lenses. Shelf-life and transport stability testing
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-10-31
- 实施
- 2014-10-31
Ophthalmic instruments - Ophthalmometers (ISO 10343:2014); German version EN ISO 10343:2014
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-10-01
- 实施
Dieser Teil von ISO 11979 legt Prufverfahren fest, mit denen die Haltbarkeit steriler Intraokularlinsen (IOL) in ihrer Endverpackung bestimmt werden kann. Diese Prufverfahren beinhalten Verfahren zur Bestimmung der Haltbarkeit von IOL wahrend Auslieferung und Lagerung.
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-10
- 实施
This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-10
- 实施
This International Standard specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods for determination of discard date as informative annexes. This test is applicable to products for up to a 28-day discard date. The test is not applicable to sterile products packaged in unit doses for single use or multidose containers designed with physical barriers to microbial contamination (e.g. aerosol containers). NOTE 1 Principles of the test can be used to extend discard dating beyond 28 d. See Annexes B, C, D and E. NOTE 2 Use of multiple or mixed microbial challenges and/or inclusion of contact lenses or other organic load can influence the apparent antimicrobial activity of a particular product. The evaluation of these variables together with testing against a larger panel of microorganisms and testing of samples from partially used containers can be of value in developing a contact lens care product, but are excluded from the scope of this International Standard.
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-10
- 实施
Ophthalmic implants. Intraocular lenses. Clinical investigations
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-09-30
- 实施
- 2014-09-30
Ophthalmic optics. Contact lens care products. Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-09-30
- 实施
- 2014-09-30
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-09-01
- 实施
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT@ hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and content of that clause or subclause will say so. If that is not the case@ the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS@ as relevant. 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.
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
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-09-01
- 实施
- 2016-10-25
Ophthalmic implants. Intraocular lenses. Optical properties and test methods
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-08-31
- 实施
- 2014-08-31
This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic intraocular lenses (PIOL).
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-08-01
- 实施
Dieser Teil von ISO 11979 legt Anforderungen und Prufverfahren fur bestimmte optische Eigenschaften von spharischen, aspharischen, monofokalen, torischen, multifokalen und/oder akkommodierenden Intraokularlinsen (IOL) fest. Die Bezeichnung "IOL", die in diesem Dokument verwendet wird, schliest auch phake Intraokularlinsen (PIOL) ein.
Ophthalmic Implants - Intraocular Lenses - Part 2: Optical Properties and Test Methods
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-08
- 实施
Ophthalmic instruments. Ophthalmometers
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-07-31
- 实施
- 2014-07-31
This International Standard, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer have sufficient resolution and range (see Table 2) to adequately measure the radii of curvature of contact lenses complying with ISO 18369-3:2006, 4.1.3, and Clause 5. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal. This International Standard takes priority over ISO 15004-1, if differences exist.
Ophthalmic instruments - Ophthalmometers
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-07-01
- 实施
本标准规定了人工晶状体植入系统的适用范围、要求、试验方法、标志和使用说明书、包装、运输和贮存。本标准适用于一体式(预装式)或分离式人工晶状体植入系统(以下简称植入系统:包含推注器、导人头等部件)。植入系统用于在白内障摘除后或在眼屈光手术中将可折叠人工晶状体折叠并注入晶状体囊袋内或睫状沟内。
Ophthalmic optics.Injection system of intraocular lenses
- ICS
- 11.040.70
- CCS
- C32
- 发布
- 2014-06-17
- 实施
- 2015-07-01
