PD CEN ISO/TS 17664-3:2026

This standard PD CEN ISO/TS 17664-3:2026 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process. The cleaning classification category is comprised of two parts: designate medical devices to a product family; designate product families to cleaning processes. NOTE 1        This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation. This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned. This document does not cover processing of single-use medical devices provided as sterile before use and textile devices. NOTE 2        Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified. NOTE 3        Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device cleaning classification categories.

PD CEN ISO/TS 17664-3:2026 - Processing of Health Care Products

Welcome to the future of medical device processing with the PD CEN ISO/TS 17664-3:2026 standard. This comprehensive document is an essential resource for medical device manufacturers, healthcare professionals, and anyone involved in the processing and maintenance of reusable medical devices. Released on July 8, 2026, this standard is the latest in ensuring the highest levels of safety and efficiency in healthcare environments.

Overview

The PD CEN ISO/TS 17664-3:2026 standard provides detailed guidance on the information that must be provided by medical device manufacturers for the effective processing of medical devices. It specifically focuses on the designation of reusable medical devices to a cleaning classification, ensuring that each device is processed according to its specific requirements.

Key Features

• Standard Number: PD CEN ISO/TS 17664-3:2026
• Pages: 22
• Release Date: July 8, 2026
• ISBN: 978 0 539 26281 0
• Status: Standard

Why This Standard is Essential

In the fast-paced world of healthcare, ensuring the cleanliness and safety of medical devices is paramount. The PD CEN ISO/TS 17664-3:2026 standard is designed to provide clear and concise guidance to manufacturers, helping them to classify their devices correctly and provide the necessary information for their safe and effective processing. This not only helps in maintaining the integrity of the devices but also ensures patient safety and compliance with regulatory requirements.

Comprehensive Guidance

This standard offers a comprehensive framework for the classification of reusable medical devices, detailing the necessary steps and considerations for their cleaning and maintenance. By following the guidelines set out in this document, manufacturers can ensure that their devices are processed in a manner that meets the highest standards of hygiene and safety.

Enhanced Safety and Compliance

With the PD CEN ISO/TS 17664-3:2026 standard, healthcare facilities can enhance their safety protocols and ensure compliance with international regulations. This standard provides the necessary tools to classify devices accurately, ensuring that each device is cleaned and maintained according to its specific needs, thereby reducing the risk of contamination and infection.

Who Should Use This Standard?

This standard is an invaluable resource for:

• Medical Device Manufacturers
• Healthcare Professionals
• Quality Assurance Teams
• Regulatory Compliance Officers
• Hospital and Clinic Administrators

Conclusion

The PD CEN ISO/TS 17664-3:2026 standard is a critical tool for anyone involved in the processing of medical devices. By providing clear guidance on the classification and cleaning of reusable medical devices, this standard helps to ensure the highest levels of safety and compliance in healthcare settings. Whether you are a manufacturer, healthcare professional, or compliance officer, this standard is an essential addition to your toolkit.

Stay ahead in the healthcare industry by adopting the PD CEN ISO/TS 17664-3:2026 standard and ensure that your medical devices are processed with the utmost care and precision.