ISO 16061:2021
与非有源外科植入物共同使用的仪器. 一般要求

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

标准号

ISO 16061:2021

发布

2021年

发布单位

国际标准化组织

当前最新

ISO 16061:2021

 

 

引用标准

ISO 10993-1 ISO 11135 ISO 11137-1 ISO 11137-2 ISO 11137-3 ISO 11607-1 ISO 11607-2 ISO 14155 ISO 14937 ISO 14971 ISO 17664 ISO 17665-1 ISO 25424 ISO 80000-1 ISO 8601-1

适用范围

This document specifies the general requirements for instruments to be used in association with nonactive 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.

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