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).
For brevity, this Standard will be referred to as “CAN/CSA-ISO 17664” throughout.
This Standard was reviewed for Canadian adoption by the SCC Mirror Committee to ISO/TC 198, under the jurisdiction of the CSA Technical Committee on Medical Device Reprocessing and the CSA Strategic Steering Committee on Health Care Technology & Systems, and has been formally approved by the Technical Committee.
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
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.
