ISO 14630:2012规定了非活性外科植入物的一般要求。ISO 14630:2012不适用于牙科植入物、牙科修复材料、经牙髓和经牙根植入物、眼内透镜和利用活动物组织的植入物。 关于安全，ISO 14630:2012规定了制造商提供的预期性能、设计属性、材料、设计评估、制造、灭菌、包装和信息的要求，以及证明符合这些要求的测试。

ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.