ISO/CD TS 20327

A draft is being reviewed by the committee.

Abstract

This document provides requirements and guidance for risk management, process design and operational aspects of receiving, handling, transporting, distributing, and storing of packaged sterile medical devices under the control of health care facilities until the point of use. The scope includes packaged sterile medical devices sterilized at the health care facility as well as those received from external suppliers or third-party reprocessing service providers. Excluded from the scope of this document are: - aseptic presentation at the point of use; - processing prior to and including sterilization of medical devices that are intended to be sterile; - handling and storing of packaged sterile medical devices in mobile care services (e.g., ambulances) or home care; - ensuring traceability of packaged sterile medical devices; - management of packaging waste.