Standard number: | BS ISO 5833:2002 |
Pages: | 30 |
Released: | 2002-06-24 |
ISBN: | 0 580 39219 8 |
Status: | Standard |
BS ISO 5833:2002
This standard BS ISO 5833:2002 Implants for surgery. Acrylic resin cements is classified in these ICS categories:
- 11.040.40 Implants for surgery, prosthetics and orthotics
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.