YY/T 0640-2016 in English

本标准规定了无源外科植入物的通用要求。本标准适用于除齿科植入物、齿科修复材料、经牙髓牙根植入物、人工晶状体和有活力动物组织植入物之外的无源外科植入物。

Scope

This standard specifies the general requirements for passive surgical implants (hereinafter referred to as implants). This standard does not apply to dental implants, dental restorative materials, transendodontic root implants, intraocular lenses and implants of viable animal tissue. With regard to safety aspects, this standard specifies requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the manufacturer, as well as tests to verify compliance with these requirements. Other tests are given in secondary and tertiary standards.