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BS EN ISO 9713:2022 – TC

BS EN ISO 9713:2022 – TC

$134.27

Tracked Changes. Neurosurgical implants. Self-closing intracranial aneurysm clips

Published By Publication Date Number of Pages
BSI 2022 50
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PDF Catalog

PDF Pages PDF Title
1 30451759
33 A-30371806
34 undefined
36 European foreword
Endorsement notice
38 Foreword
39 Introduction
41 1 Scope
2 Normative references
3 Terms and definitions
42 4 Description of aneurysm clips
4.1 Mechanism of action
4.2 Geometry
4.3 Blade closing surface
43 5 Indication of dimensions
6 Materials
45 7 MRI safety assessment
8 Design requirements
8.1 Closing force
8.1.1 Measurement of actual closing force of clips
46 8.1.2 Tolerance on nominal closing force
8.1.3 Reduction of closing force
8.2 ​Verification of blade surface
8.3 ​Assessment of maximum blade opening
9 Supplying condition and sterilization
10 Packaging
47 11 Information supplied by the manufacturer
11.1 General
11.2 Implant processing by user
11.3 Label
11.4 Instructions for use
11.5 Information for the patient
11.5.1 General
48 11.5.2 Patient record label
11.5.3 Patient card
49 Bibliography

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BS EN ISO 9713:2022 - TC
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