ISO 15004-2 PDF

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iwo You may experience issues viewing this site in Internet Explorer 9, 10 or Light hazard protection Status: Your basket is empty. BS EN ISO specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective international standards.

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FDA recognition of ANSI Z – Ophthalmic Instruments – Bentham

Take the smart route to manage medical device compliance. Accept and continue Learn more about the cookies we use and how to change your settings. Overview Product Details BS EN ISO specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective international standards.

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BS EN ISO classifies ophthalmic instruments into either Group 1 or Group 2 in order to distinguish instruments that are non-hazardous from those that are 1504-2 hazardous. BS EN ISO is also applicable to all new and emerging ophthalmic instruments that direct optical radiation 150042 or at the eye. Hazards, Clinical investigation instruments, Ophthalmic equipment, Optical instruments, Classification systems, Instructions for use, Equipment safety, Wavelengths, Optical measurement, Eyes, Medical equipment, Safety measures, Light hazards, Ophthalmology, Light emission.

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BS EN ISO 15004-2:2007

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Please download Chrome or Firefox or view our browser tips. Fundamental requirements and test methods General requirements applicable to all ophthalmic instruments. Fundamental requirements and test methods.