ISO 10940:2009, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis. ISO 10940:2009 takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
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Sisällysluettelo
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Optical properties
4.3 Construction and function
4.4 Optical radiation hazard with fundus cameras
5 Test methods for checking the optical properties
5.1 General
5.2 Test target arrangement
5.3 Checking the resolving power of the fundus camera optics
5.4 Checking the angular field of view
5.5 Checking the magnification of the image
5.6 Checking the pixel pitch of a sensor on the fundus
6 Accompanying documents
7 Marking
Annex A Guidance for the measurement and calculation of the light hazard related values (normative)
Annex B Guidance for safe use of the fundus camera (informative)
IEC 60601-1:2005
ISO 15004-1:2006 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 1: General requirements applicable to all ophthalmic instruments
ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection
IEC 60601-1:2005
ISO 15004-1:2006 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 1: General requirements applicable to all ophthalmic instruments
ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection