CAN/CSA-ISO 17664:18

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

CSA Preface This is the second edition of CAN/CSA-ISO 17664, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 17664 (second edition, 2017-10). It supersedes the previous edition published in 2006 as CAN/CSA-Z17664, Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (adopted ISO 17664:2004). Scope This document specifies requirements for 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. This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices not intended for direct patient contact; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single-use only and supplied ready for use.

CSA Preface This is the second edition of CAN/CSA-ISO 17664, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 17664 (second edition, 2017-10). It supersedes the previous edition published in 2006 as CAN/CSA-Z17664, Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (adopted ISO 17664:2004). Scope This document specifies requirements for 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. This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices not intended for direct patient contact; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single-use only and supplied ready for use.