BS EN ISO 3630-4:2023 – TC

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Tracked Changes. Dentistry. Endodontic instruments – Auxiliary instruments

Published By	Publication Date	Number of Pages
BSI	2023	64

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Categories: 11.060.20 - Dental equipment, BSI

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This document specifies requirements and test methods for hand-held or mechanically operated auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers, explorers, cotton broaches and cannulae. This document specifies requirements for size, product designation, safety considerations, instructions and labelling.

PDF Catalog

PDF Pages	PDF Title
40	undefined
42	European foreword Endorsement notice
44	Foreword
45	1 Scope 2 Normative references 3 Terms and definitions
46	4 Classification and symbols 4.1 Classification 4.2 Symbols
47	5 Requirements 5.1 Material 5.2 Dimensions 5.2.1 General 5.2.2 Barbed broaches — Type 1 instruments
48	5.2.3 Paste carriers — Type 2 instruments
49	5.2.4 Explorers and cotton broaches — Type 3 instruments
50	5.2.5 Cannulae — Type 4 instruments
51	5.3 Colour designation and size marking with rings 5.4 Mechanical requirements 5.4.1 Resistance to fracture by twisting (torque) and angular deflection — Types 1 and 3
52	5.4.2 Stiffness — Resistance to bending — Types 1 and 3 5.4.3 Handle or shank security — Types 1, 2 and 3 instruments 5.4.4 Resistance to fatigue — Type 2
53	5.4.5 Resistance to breakage or cracking — Type 4 5.5 Reprocessing 5.6 Heat effects of sterilization 5.6.1 General 5.6.2 Single-use instruments (supplied non-sterile) 5.6.3 Multi-use instruments 6 Sampling
54	7 Testing 7.1 General 7.2 Dimensions 7.2.1 General 7.2.2 Barbed broaches
55	7.2.3 Paste carriers — Type 2 instruments 8 Product information 8.1 Marking
56	8.2 Labelling 8.3 Packaging 8.4 Instructions for use
57	Annex A (normative) Test method for resistance of cannula to breakage or cracking
62	Annex B (normative) Test method for resistance of cannula to corrosion
63	Bibliography