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This National Standard of Canada is equivalent to International Standard ISO 5832-6:1997. 1 Scope This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel-chromium-molybdenum alloy for use in the manufacture of surgical implants. NOTE - The mechanical properties of a sample obtained from a finished product made of this alloy…

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…

This National Standard of Canada is equivalent to International Standard ISO 5835:1991. 1 Scope This International Standard specifies dimensions and tolerances for metal bone screws used in surgery, having hexagonal drive connection, spherical under-surface of the head, and shallow and deep asymmetrical threads. NOTEs 1 The mechanical requirements for screws that are cited in…

This National Standard of Canada is equivalent to International Standard ISO 7206-2:1996. 1 Scope This part of ISO 7206 specifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, as follows: a) sphericity and surface finish requirements for metallic and ceramic…

This National Standard of Canada is equivalent to International Standard ISO 7207-1:1994. 1 Scope This part of ISO 7207 classifies femoral and tibial components for knee joint prostheses in which one or both bearing surfaces of at least one compartment of the knee are replaced, and gives definitions of components and the designation of dimensions. Patellar components and prostheses…

This National Standard of Canada is equivalent to International Standard ISO 8319-1:1996. 1 Scope This part of ISO 8319 specifies the dimensions, tolerances, mechanical properties and performance requirements of the working end of keys to be used for inserting and removing metal bone screws with hexagon drive sockets, used as surgical implants. Screw keys with a working end specified…

This National Standard of Canada is equivalent to International Standard ISO 8319/2-1986. 1 Scope and field of application This part of ISO 8319 specifies requirements for screwdrivers used in orthopaedic surgery for inserting and removing bone screws with single slot heads, with cruciate slot or cross-recessed heads. Screwdrivers specified in this part of ISO 8319 are suitable for use…

This National Standard of Canada is equivalent to International Standard ISO 10993-9:1999. 1 Scope This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. This part of ISO 10993 is not applicable to: a) viable-tissue engineered…

This National Standard of Canada is equivalent to International Standard ISO 10993-13:1998. 1 Scope This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation…

This National Standard of Canada is equivalent to International Standard ISO 10993-16:1997. 1 Scope This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.