ISO 16061:2021 与非活动外科植入物配套使用的仪器 一般要求

标准编号：ISO 16061:2021

中文名称：与非活动外科植入物配套使用的仪器 一般要求

英文名称：Instruments for use in association with non-active surgical implants — General requirements

发布日期：2021-03

标准范围

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.

标准预览图