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BS EN ISO 16061:2021

BS EN ISO 16061:2021

$142.49

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

Published By Publication Date Number of Pages
BSI 2021 24
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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
2 National foreword
4 European foreword
6 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
4 Intended performance
11 5 Design attributes
12 6 Selection of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
13 7.3 Clinical evaluation
7.4 Post-market surveillance
14 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
15 10.2 Maintenance of sterility in transport, storage and handling
11 Information supplied by the manufacturer
11.1 General
16 11.2 Marking on instruments
11.3 Label
17 11.4 Instructions for use
18 11.5 Additional information for instruments with a measuring function
19 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
21 Bibliography

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BS EN ISO 16061:2021
$142.49