Canadian Medical Devices Reprocessing

Designation Number:
Z314
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
New Edition
ICS code(s):
11.040.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This Standard addresses the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow and it provides MDR  specific requirements for QMS, personnel, MIFUs, purchase and evaluation of medical devices, procedures for loaned and reusable medical devices, work area and design, environmental conditions, utilities, reprocessing workflow, sterile storage, selectin and use of gowns and drapes, as well as  laundering, maintenance, and preparation of reusable gowns, drapes and wrappers.

Project need:

To support innovation in the field of MDR by providing requirements for the safe, effective, and reliable reprocessing of reusable medical devices in the Canadian context and to maintain alignment with international requirements for sterilization. To improve content and usability of the 1st consolidated version of Z314 Standard published in 2018.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.