Standards Development
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). 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 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.
All requirements apply to, and all tests are intended to be performed on, the sterile product.
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