标准编号：ISO 16061:2015
中文名称：与无源外科植入物联合使用的仪器 一般要求
英文名称：Instrumentation for use in association with non-active surgical implants — General requirements
发布日期：2015-05
标准范围
This International Standard specifies general requirements for instruments to be used in association withnon-active surgical implants. These requirements apply to instruments when they are manufacturedand when they are resupplied after refurbishment.This International Standard also applies to instruments which may be connected to power-drivensystems, but does not apply to the power-driven systems themselves.With regard to safety, this International Standard gives requirements for intended performance, designattributes, materials, design evaluation, manufacture, sterilization, packaging, and information suppliedby the manufacturer.This International Standard is not applicable to instruments associated with dental implants,transendodontic and transradicular implants, and ophthalmic implants.
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