Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes
  identified in the information
  provided by the medical device
  manufacturer
5 Risk analysis
6 Information to be provided by
  the medical device manufacturer
7 Presentation of the information
Annex A (informative) - Commonly utilized
                        processing methods
Annex B (informative) - Example of processing
                        instructions for reusable
                        medical devices
Annex C (informative) - Classification of medical
                        devices
Annex D (informative) - Additional guidance
                        on information to be
                        provided by the medical
                        device manufacturer
Bibliography

Abstract

Describes the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN