BS EN ISO 11980-2009 眼科光学.隐形眼镜和隐形眼镜防护产品.临床检测指南

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                   【英文标准名称】:     Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations            【原文标准名称】:     眼科光学.隐形眼镜和隐形眼镜防护产品.临床检测指南            【标准号】:     BS EN ISO 11980-2009            【标准状态】:     现行            【国别】:     英国            【发布日期】:     2009-11-30    【实施或试行日期】: 2009-11-30【发布单位】: 英国标准学会(GB-BSI)【起草单位】: BSI【标准类型】: ()【标准水平】: ()【中文主题词】: 对视力的帮助;清洗材料;临床调查;临床试验;接触镜片;每日的;消毒;眼科光学;眼科学;光学仪器;光学;防腐剂;安全;规范(验收);试验结果;测试;使用【英文主题词】: Aid to vision;Cleaning materials;Clinical investigations;Clinical testing;Contact lenses;Daily;Disinfections;Ophthalmic optics;Ophthalmology;Optical instruments;Opticsreservative agents;Safety;Specification (approval);Test results;Testing;Use【摘要】: This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.NOTE This International Standard attempts to harmonize the recognized regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world.However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this International Standard.【中国标准分类号】: Y89【国际标准分类号】: 11_040_70【页数】: 38P.;A4【正文语种】: 英语