CSA ISO 17664-1:23
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07)
This is the first edition of CSA ISO 17664-1, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard ISO 17664-1 (first edition, 2021-07). This Standard and CSA ISO 17664-2 replace CAN/CSA-ISO 17664:18 (adopted ISO 17664:2017), Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices.
For brevity, this Standard will be referred to as “CSA ISO 17664-1” throughout.
CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).
This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Medical Device Reprocessing, under the jurisdiction of the Strategic Steering Committee on Health and Well-being, 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.
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
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;
f) inspection and maintenance;
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— 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.
NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.