ISO 14630:2012规定了非主动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，经牙根管和晶状体植入物，眼内镜片和使用活的动物组织的植入物。 关于安全性，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.