MEDICAL EQUIPMENT, SURGICAL IMPLANTS, ORTHOPAEDIC IMPLANTS, BONE CEMENTS,ACRYLIC RESINS, SPECIFICATIONS, TESTS, PACKAGING, MARKING LABELLING
被代替标准
CAN/CSA-Z310.12-M91
适用范围
This National Standard of Canada is equivalent to International Standard ISO 5833:1992. 1 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 tests are to be performed on, the sterile
product.