This document 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). This document 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.

All requirements in this document apply to, and all test methods are intended to be performed on, a sterile product.

The requirements in this document are not intended to apply to acrylic resin cements for other applications, such as stabilization of spinal fractures, fixation of bone screws, bone anchors or augments, etc., although the test methods described can be applicable.

This document does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.