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Scope

This International Standard applies to radio-opaque and non- radio-opaque cements and specifies physical, mechanical, packaging and labelling requirements for self-curing resin cement based on poly(methacrylic acid esters), of two types 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 the tests are to be performed on, the sterile product.