BAS EN ISO 15004-1:2010
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
General Information
Status: Withdrawn
No. of pages: 13
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
Lifecycle
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Original document and degree of correspondence
- EN ISO 15004-1:2009, identical
- ISO 15004-1:2006, identical