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BS ISO 8600-1:2015 – TC:2020 Edition

BS ISO 8600-1:2015 – TC:2020 Edition

$134.27

Tracked Changes. Endoscopes. Medical endoscopes and endotherapy devices – General requirements

Published By Publication Date Number of Pages
BSI 2020 43
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PDF Catalog

PDF Pages PDF Title
1 compares BS ISO 8600-1:2015
2 TRACKED CHANGES
Text example 1 — indicates added text (in green)
4 Endoscopes — Medical endoscopes and endotherapy devices —
Part 1:
5 COPYRIGHT PROTECTED DOCUMENT
6 ISO 8600-1:20132015(E)
7 Foreword
8 INTERNATIONAL STANDARD ISO 8600-1:20132015(E)
3 Terms and definitions
3.1
9 3.2
3.3
3.4
3.5
3.6
3.7
3.8
10 3.9
3.10
3.11
3.12
3.13
11 Figure 1 — Field of view
12 Figure 2 — Direction of view
3.16
3.17
Figure 3 — Angle of deflection
13 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
4.7 Safety
4.8 Biological compatibility
4.9 Fittings/connectors for liquid or gaseous media
14 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
4.10.5 Maximum angle of deflection
5 Testing
5.1 General
5.2 Surface and edges
5.3 Maximum insertion portion width
15 a) Hand wheel up-down deflection control system for controllable portion
b) Hand wheel right-left deflection control system for controllable portion
Figure 4 — Hand wheels for up-down deflection and right-left deflection
16 5.4 Minimum instrument channel width
5.5 Field of view
5.6 Direction of view
6 Marking
6.1 Minimum marking
6.2 Marking legibility
6.3 Marking exceptions
7 Instruction manual
17 8 Packaging
18 Annex A
Guidelines on the application of risk management to endoscopic system connector
20 Bibliography
21 ICS 11.040.55
27 Foreword
28 1 Scope
2 Normative references
3 Terms and definitions
32 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
33 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
34 4.10.5 Maximum angle of deflection
5 Testing
5.1 General
5.2 Surface and edges
5.3 Maximum insertion portion width
35 5.4 Minimum instrument channel width
5.5 Field of view
5.6 Direction of view
6 Marking
6.1 Minimum marking
36 6.2 Marking legibility
6.3 Marking exceptions
7 Instruction manual
37 8 Packaging
38 Annex A (informative) Guidelines on the application of risk management to endoscopic system connector
40 Bibliography

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BS ISO 8600-1:2015 - TC
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