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BS EN ISO 7551:2023

BS EN ISO 7551:2023

$102.76

Dentistry. Endodontic absorbent points

Published By Publication Date Number of Pages
BSI 2023 22
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This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Requirements
4.1 Appearance
4.2 Length
11 4.3 General
4.4 Nominal size designation tolerances
13 4.5 Colour-coding
4.6 Taper
4.7 Absorption
4.8 Disintegration
5 Procurement of samples
6 Measurement and test methods
6.1 Test conditions
14 6.2 Visual examination
6.3 Length
6.3.1 Apparatus
6.3.2 Method
6.4 Taper and nominal size measurements
6.4.1 Apparatus
6.4.2 Method for standard and greater taper points
16 6.4.3 Method for variable taper absorbent points
6.5 Absorption
6.5.1 Apparatus
17 6.5.2 Material
6.5.3 Method
6.5.4 Interpretation of results
7 Product information
7.1 Marking
7.2 Packaging
7.3 Labelling
20 Bibliography

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BS EN ISO 7551:2023
$102.76