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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.

This National Standard of Canada is equivalent to International Standard ISO/IEC ISP 11190:1995. 1 Scope 1.1 General ISO/IEC ISP 10616 profiles information to be stored within the Directory which is common to a variety of applications. This International Standardized Profile augments this information with FTAM specific information. Statements and conformance requirements stated in ISO/…

This National Standard of Canada is equivalent to International Standard ISO/IEC ISP 12059-13:1996. 1. Scope 1.1 General This part of ISO/IEC ISP 12059 is based on ITU-T Rec. X.738 / ISO/IEC 10164-13, Summarization function. This part of ISO/IEC ISP 12059 is used by ISO/IEC ISP 12060 parts as building blocks for subdividing systems management functional capabilities and generating a set…

This National Standard of Canada is equivalent to International Standard ISO/IEC ISP 12063-1:1997. 1 Scope 1.1 General This part of ISO/IEC ISP 12063 contains the overall specifications of the support of MHS Elements of Service and associated MHS functionality in an Electronic Data Interchange Messaging (EDIMG) environment which are generally not appropriate for consideration only from…

This National Standard of Canada is equivalent to International Standard ISO/IEC ISP 12063-4:1997. 1 Scope 1.1 General This part of ISO/IEC ISP 12063 covers access to a Message Transfer System (MTS) in an EDI Messaging (EDIMG) environment using the P3 MTS Access Protocol (see also figure 1). These specifications form part of the EDI Messaging application functions, as defined in the…

This National Standard of Canada is equivalent to International Standard ISO/IEC ISP 12063-5:1997. 1 Scope 1.1 General This part of ISO/IEC ISP 12063 covers access to a message store (EDI-MS) in an EDI Messaging (EDIMG) environment using the P7 MS Access Protocol (see also figure 1). These specifications form part of the EDI Messaging application functions, as defined in the parts of…

This National Standard of Canada is equivalent to International Standard ISO/IEC 14363:1996. 1.1 Scope This International Standard defines requirements for test methods for measuring conformance to ISO/IEC 14361 {3}. ISO/IEC 14361 {3} is stated in terms that are independent of any particular programming language, but each implementation that conforms to it implements a particular…