11.040.40;11.040.99 标准查询与下载

BS EN ISO 16061:2015 与非有源外科植入物共同使用的器械.一般要求

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

KS P ISO 16061:2014 与无源外科植入物联合使用的仪器 一般要求

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

BS EN ISO 16061:2009 与非有源外科植入物共同使用的器械.一般要求

This International Standard specifies 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 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, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

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

EN ISO 16061:2009 与非活性外科植入物联合使用的仪表装置.一般要求

This International Standard 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.

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