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eLibrary > 23/30451302 DC Draft BS ISO 16971-1 Ophthalmic instruments . Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye >

23/30451302 DC Draft BS ISO 16971-1 Ophthalmic instruments . Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye, 2023

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23/30451302 DC Draft BS ISO 16971-1 Ophthalmic instruments . Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye, 2023

30451302-NC.pdf
ISO_DIS 16971-1 ed.1 - id.83360 Enquiry PDF (en).pdf [Go to Page]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
4 Requirements [Go to Page]
4.1 General
4.2 Construction and function [Go to Page]
4.2.1 Optical properties and specifications
4.2.2 Tolerance requirements
4.2.3 Co-alignment of fundus image and OCT hardware
4.2.4 Light hazard protection
4.3 Analysis and presentation of results [Go to Page]
4.3.1 Presentation of structural OCT images
4.3.2 Retinal thickness measurement
4.3.3 Reference database
4.4 Data exchange
5 Recommended test methods [Go to Page]
5.1 General
5.2 Measurement setups
5.3 Test methods for optical properties [Go to Page]
5.3.1 Lateral optical resolution
5.3.2 Axial optical resolution
5.3.3 Axial range
5.3.4 Angular field of view
5.4 Test methods for signal quality [Go to Page]
5.4.1 Sensitivity
5.4.2 Axial signal roll-off
5.5 Co-alignment of fundus image and OCT scan [Go to Page]
5.5.1 General
5.5.2 En-face method
5.5.3 Line scan method
6 Information to be supplied by the manufacturer [Go to Page]
6.1 General [Go to Page]
6.1.1 Warnings and safety-related information
6.1.2 Maintenance
6.2 Technical description [Go to Page]
6.2.1 Imaging parameters
6.2.2 Acquisition and scan modes
6.2.3 Measurements and data analysis
6.2.4 Data exchange
6.3 Information available on request
7 Marking
Annex€A (informative) Example for test devices
Bibliography [Go to Page]

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23/30451302 DC Draft BS ISO 16971-1 Ophthalmic instruments . Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye, 2023

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