ISO 5833:2002 外科植入物.丙烯酸树脂粘接剂

标准编号：ISO 5833:2002

中文名称：外科植入物.丙烯酸树脂粘接剂

英文名称：Implants for surgery — Acrylic resin cements

发布日期：2002-05

标准范围

本国际标准规定了基于聚甲基丙烯酸酯固化聚合射光不透明和非射光不透明树脂水泥的物理、机械、包装和标签要求。它适用于两种类型的水泥，分别用于注射器或面团状态，用于固定骨科内假体，并作为含有预先测量量的无菌粉末和无菌液体的单元供应，其形式适合在植入时混合。本国际标准不包括与患者或水泥使用者使用水泥相关的危险。所有要求均适用于无菌产品，所有测试均针对无菌产品进行。

This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.All requirements apply to, and all tests are intended to be performed on, the sterile product.

标准预览图