ISO-15004-2 › Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
The following bibliographic material is provided to assist you with your purchasing decision:
ISO 15004-2:2007 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. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.
ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.
ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
SOR/98-282Medical Devices Regulations (Canada)
ISO-13485
Medical devices - Quality management systems - Requirements for regulatory purposes
ISO-14971
Medical devices - Application of risk management to medical devices
Document Number
ISO 15004-2:2007
Revision Level
1ST EDITION
Status
Current
Publication Date
Feb. 15, 2007
Committee Number
ISO/TC 172/SC 7