YY 0334-2002 in English
SUPERSEDEDGeneral specification for surgical implants made of silicone elastomer
- Issued on:2002-04-25
- Implemented on:2002-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$165.00
本标准规定了硅橡胶外科植入物的化学及生物性能、无菌、包装和标志的通用要求。未规定植入物的物理机械性能的具体指标。这些植入物主要用于外科矫形与修复。硅橡胶与其他材料在一起的外科植入物不包括在本标准范围内。
Scope
This standard specifies general requirements for the chemical and biological properties, sterility, packaging and labeling of silicone rubber surgical implants. Specific indicators of the physical and mechanical properties of the implant are not specified. These implants are mainly used for surgical orthopedics and repair. Surgical implants made of silicone rubber together with other materials are not included in the scope of this standard.
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