BS ISO 5833:2002

1 Scope
2 Term and definition
3 Liquid component
4 Powder component
5 Liquid-powder mixture intended for syringe usage
6 Liquid-powder mixture intended for use in dough state
7 Set and polymerized cement
8 Packaging
9 Labelling
Annexes
A Determination of stability of liquid component
B Determination of doughing time of liquid-powder
  mixture of cement intended for dough usage
C Determination of maximum temperature and setting
  time of liquid-powder mixture
D Determination of intrusion of liquid-powder
  mixture of cement intended for dough usage
E Determination of compressive strength of polymerized
  cement
F Determination of bending modulus and bending strength
  of polymerized cement

Describes the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters).

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.