ISO 16061:2015

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

Published By	Publication Date	Number of Pages
ISO	2015-05	24

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, 11.040.99 - Other medical equipment, ISO

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Description

ISO 16061:2015 specifies 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 resupplied after refurbishment.

This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.

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

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2015-05
Pages Count	24
Language	English
Edition	3
File Size	337.9 KB
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics 11.040.99 - Other medical equipment

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ISO 16061:2015

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