標準號：BS EN ISO 16061-2009
中文標準名稱：與非有源外科植入物共同使用的器械.一般要求
英文標準名稱：Instrumentation for use in association with non-active surgical implants - General requirements
標準類型：C35
發布日期：2009/12/31 12:00:00
實施日期：2009/12/31 12:00:00
中國標準分類號：C35
國際標準分類號：11.040.40;11.040.99
引用標準：ISO 11135-1;ISO 11137-1;ISO 11137-2;ISO 11137-3;ISO 11607-1;ISO 11607-2;ISO 14155-1;ISO 14155-2;ISO 14971;ISO 15223-1;ISO 17664;ISO 17665-1;EN 556-1;EN 556-2;EN 1041
適用范圍：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, designattributes, 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.