标准号:ISO 5833-2002
中文标准名称:外科植入物.丙烯酸树脂粘接剂
英文标准名称:Implants for surgery - Acrylic resin cements
标准类型:C35
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C35
国际标准分类号:11.040.40
适用范围: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.