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BSI 23/30451302 DC:2023 Edition

$13.70

Draft BS ISO 16971-1 Ophthalmic instruments . Optical coherence tomographs – Part 1: Optical coherence tomographs for the posterior segment of the human eye

Published By Publication Date Number of Pages
BSI 2023 25
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PDF Catalog

PDF Pages PDF Title
1 30451302-NC.pdf
3 ISO_DIS 16971-1 ed.1 – id.83360 Enquiry PDF (en).pdf
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms, definitions and symbols
14 4 Requirements
4.1 General
4.2 Construction and function
4.2.1 Optical properties and specifications
4.2.2 Tolerance requirements
15 4.2.3 Co-alignment of fundus image and OCT hardware
4.2.4 Light hazard protection
4.3 Analysis and presentation of results
4.3.1 Presentation of structural OCT images
4.3.2 Retinal thickness measurement
4.3.3 Reference database
16 4.4 Data exchange
5 Recommended test methods
5.1 General
5.2 Measurement setups
5.3 Test methods for optical properties
5.3.1 Lateral optical resolution
17 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
5.4.1 Sensitivity
18 5.4.2 Axial signal roll-off
5.5 Co-alignment of fundus image and OCT scan
5.5.1 General
5.5.2 En-face method
5.5.3 Line scan method
19 6 Information to be supplied by the manufacturer
6.1 General
20 6.1.1 Warnings and safety-related information
6.1.2 Maintenance
6.2 Technical description
6.2.1 Imaging parameters
21 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
22 Annex€A (informative) Example for test devices
24 Bibliography
BSI 23/30451302 DC
$13.70