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Standard ČSN EN ISO 16061 1.10.2021 preview

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ČSN EN ISO 16061 (852940)

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

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STANDARD published on 1.10.2021


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The information about the standard:

Designation standards: ČSN EN ISO 16061
Classification mark: 852940
Catalog number: 512717
Publication date standards: 1.10.2021
SKU: NS-1036942
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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Implants for surgery, prosthetics and orthoticsOther medical equipment

Annotation of standard text ČSN EN ISO 16061 (852940):

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

Preview of the standard ČSN EN ISO 16061 (852940)

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