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BS ISO 8600-1:2015

$102.76

Endoscopes. Medical endoscopes and endotherapy devices – General requirements

Published By Publication Date Number of Pages
BSI 2015 22
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This part of ISO 8600 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

PDF Catalog

PDF Pages PDF Title
6 Foreword
7 1 Scope
2 Normative references
3 Terms and definitions
11 4 Requirements
4.1 General
4.2 Surface and edges
4.3 Maximum insertion portion width
4.4 Minimum instrument channel width
4.5 Field of view
4.6 Direction of view
12 4.7 Safety
4.8 Biological compatibility
4.9 Fittings/connectors for liquid or gaseous media
4.10 Deflection control system for the controllable portion
4.10.1 General
4.10.2 Deflection up and down
4.10.3 Deflection right and left
4.10.4 Arrangement of the hand wheels
13 4.10.5 Maximum angle of deflection
5 Testing
5.1 General
5.2 Surface and edges
5.3 Maximum insertion portion width
14 5.4 Minimum instrument channel width
5.5 Field of view
5.6 Direction of view
6 Marking
6.1 Minimum marking
15 6.2 Marking legibility
6.3 Marking exceptions
7 Instruction manual
16 8 Packaging
17 AnnexĀ A (informative) Guidelines on the application of risk management to endoscopic system connector
19 Bibliography
BS ISO 8600-1:2015
$102.76