90.93 Standard confirmed Nov 14, 2019
ISO
ISO/TC 150/SC 1 Materials
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Published
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.
WITHDRAWN
ISO 5833:1992
PUBLISHED
ISO 5833:2002
90.93
Standard confirmed
Nov 14, 2019