scope:

Preface

This Is the first edition of the following CSA Standards:

CAN/CSA-Z3 1 0.7-M91, Implants for Surgery - Metallic Materials - Part II: Unalloyed Titanium;

CAN/CSA-Z310.8-M9I, Implants for Surgery - Metallic Materials - Port III: Wrought Titanium 6-Aluminum 4-Vanadium Alloy;

CAN/CSA-Z310.9-M91, Implants for Surgery - Metallic Materials - Part IV: Cobalt-Chromium-Molybdenum Casting Alloy;

CAN/CSA-Z310.10-M91, Implants for Surgery - Metallic Materials - Part V: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy;

CAN/CSA-Z310.11-M91, Implants for Surgery - Metallic Materials - Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy;

CAN/CSA-Z310.12-M91, Implants for Surgery - Acrylic Resin Cements - Part 1: Orthopaedic Applications;

CAN/CSA-Z310.13-M91, implants for Surgery - Metal Bone Screws - Dimensions - Part 1: Screws with Asymmetrical Thread, Spherical Under-Surfaces;

CAN/CSA-Z310.14-M9I, Implants for Surgery - Partial and Total Hip joint Prostheses - Part 2: Bearing Surfaces Made of Metallic and Plastics Materials;

CAN/CSA-Z310.1S-M91 (ISO 7207/1 -198S), Implants for Surgery - Partial and Total Knee Joint Prostheses - Part 1: Classification, Definitions and Designation of Dimensions;

CAN/CSA-Z310.16-M91, Orthopaedic Instruments - Drive Connections - Part 1: Keys for Use with Screws and Hexagon Socket Heads;

CAN/CSA-Z310.17-M91, Orthopaedic Instruments - Drive Connections - Part 2: Screwdrivers for Single Slot Head Screws, Screws with Cruciate Slot and Goss-Recessed Head Screws.

Deviations to the original ISO requirements are presented in the pages preceding the bulk of these Standards and constitute what are considered to be the Canadian deviations. These deviations reflect a general updating of the original ISO texts. North American practices that differ from those suggested by ISO, and Canadian health and safety concerns.

These Standards were prepared by the CSA Technical Committee on Orthopaedic Implants and were formally approved by this committee and the Standards Steering Committee on Health Care Technology. They have been approved as National Standards of Canada by the Standards Council of Canada.

September 1991

Notes:

(1) Use of the singular in this Standard does not exclude the plural (and vice versa) when the sense allows.

(2) Although the intended primary application of this Standard is staled in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.

(3) CSA Standards are subject to periodic review, and suggestions for their improvement will be referred to the appropriate committee.

(4) All enquiries regarding this Standard, induding requests for interpretation, should be addressed to Canadian Standards Assodation, Standards Division, 178 Rexdale Boulevard, Rexdale, Ontario M9W 1R3. Requests for interpretation should

(a) define the problem, making reference to the speafic clause, and, vrhere appropriate, include an illustrative sketch;

(b) provide an explanation of drcumstances surrounding the actual field condition; and

(c) be phrased where possible to permit a spedfic "yes" or "no" answer.

Interpretations are published in CSA Information Update. For subscription details and a free sample copy, write to CSA Sales Promotions or telephone (416) 747-4116.