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BS EN ISO 16061:2021 – TC

BS EN ISO 16061:2021 – TC

$186.33

Tracked Changes. Instruments for use in association with non-active surgical implants. General requirements

Published By Publication Date Number of Pages
BSI 2021 64
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This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.

NOTE

In this document, unless otherwise specified, the term “ instrument” refers to an instrument for use in association with non-active surgical implants.

This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.

With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

PDF Catalog

PDF Pages PDF Title
1 30446288
41 A-30367076
42 National foreword
44 European foreword
46 Foreword
48 Introduction
49 1 Scope
2 Normative references
50 3 Terms and definitions
4 Intended performance
51 5 Design attributes
52 6 Selection of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
53 7.3 Clinical evaluation
7.4 Post-market surveillance
54 8 Manufacture
9 Sterilization
9.1 Instruments supplied sterile
9.2 Instruments supplied non-sterile
9.3 Instruments that are resterilizable
10 Packaging
10.1 Protection from damage in transport, storage and handling
55 10.2 Maintenance of sterility in transport, storage and handling
11 Information supplied by the manufacturer
11.1 General
56 11.2 Marking on instruments
11.3 Label
57 11.4 Instructions for use
58 11.5 Additional information for instruments with a measuring function
59 Annex A (informative) Examples of typical applications of instruments to be used in association with non-active surgical implants and materials found acceptable for instrument manufacture
61 Bibliography

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BS EN ISO 16061:2021 - TC
$186.33