Definition of SN EN ISO 17664-2:2024

SN EN ISO 17664-2:2024 is a standard published by the International Organization for Standardization (ISO) that outlines the requirements for the processing of non-critical medical devices that are not intended to be sterilized. It provides guidance to medical device manufacturers on how to prepare, clean, and maintain these devices safely and effectively.

Purpose and objectives

The main objective of SN EN ISO 17664-2:2024 is to ensure that medical device manufacturers provide comprehensive processing instructions for non-critical medical devices. This includes specific procedures for preparation, cleaning, disinfection, drying, inspection, maintenance, packaging, storage, and transportation. By adhering to these guidelines, manufacturers can enhance device safety, reduce infection risks, and ensure compliance with regulatory standards, such as the EU Regulation (EU) 2017/745. Ultimately, this standard aims to protect patients and healthcare providers by promoting best practices in the handling of medical devices.

Scope: who must comply

SN EN ISO 17664-2:2024 applies to all medical device manufacturers involved in the production and processing of non-critical medical devices. This includes companies in various sectors of the healthcare technology industry, such as:

• Manufacturers of medical equipment and devices
• Hospitals and healthcare facilities that utilize these devices
• Suppliers and distributors responsible for the transport and storage of medical products

Compliance with this standard is crucial for ensuring the quality and safety of health care products, ultimately contributing to better patient outcomes and regulatory adherence.

How SN EN ISO 17664-2:2024 relates to other standards

SN EN ISO 17664-2:2024 is part of a broader set of standards related to medical device processing. It is closely related to the following standards:

• ISO 17664-1: This standard focuses on the requirements for the sterilization of medical devices, complementing the guidelines in ISO 17664-2.
• ISO 13485: A quality management standard that supports the design and manufacture of medical devices, ensuring that compliance processes are maintained throughout the product lifecycle.
• IEC 60601: This standard addresses the safety and essential performance of medical electrical equipment, providing a framework for compliance that is integral to device processing.

Revision history and current status

The SN EN ISO 17664-2:2024 was published by ISO in 2024. This latest revision includes updates that reflect current best practices in medical device processing, as well as advancements in technology and regulatory requirements. Changes in this revision aim to enhance clarity and ensure that manufacturers are equipped to meet the evolving demands of health care environments.