ISO/TS 17664-3:2026 PDF

Overview

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 - Part 3: Guidance on the designation of a reusable medical device to a cleaning classification, is an essential technical specification developed by ISO. This document delivers clear guidance for medical device manufacturers and processing facilities regarding the classification and cleaning of reusable medical devices.

The specification supports the designation of devices to cleaning classification categories and helps group devices into product families, aligning them with appropriate cleaning processes. This ensures consistent, validated cleaning methods are defined in manufacturers’ instructions for use (IFU) and implemented during actual cleaning operations.

Key Topics

• Cleaning Classification Categories: Outlines processes for categorizing medical devices based on their design, material, clinical use, and cleaning process type.

  • Manual cleaning (Categories M1–M3): From accessible surfaces to those necessitating specialized equipment.
  • Automated cleaning (Categories A1–A3): From simple surfaces to complex devices requiring specialized accessories and customized parameters.

• Product Family Designation: Provides the basis for grouping devices with similar attributes, ensuring collective validation, and efficient processing.

  • Attributes considered:
    • Geometric design features (e.g., surfaces, crevices, lumens)
    • Materials of construction
    • Clinical use
    • Type of cleaning process

• Master Product Identification: Establishes protocols for identifying the most challenging device within a product family to ensure cleaning efficacy is validated for all group members.

• Risk Analysis: Advises manufacturers and processing facilities to conduct risk assessments, especially when alternative cleaning processes are used.

• Instructions for Use (IFU): Emphasizes robust, validated cleaning instructions to guarantee effective decontamination and reduce risk across the product lifecycle.

Applications

ISO/TS 17664-3:2026 is highly relevant for:

• Medical Device Manufacturers: Assists in developing, validating, and documenting cleaning methods for reusable medical devices. Enhances product family grouping and supports regulatory compliance.
• Healthcare Processing Facilities: Enables standardized workflows, risk mitigation, and proper allocation of resources for cleaning diverse medical devices.
• Quality Assurance and Risk Management Teams: Facilitates process validation, equipment selection, and staff training according to the cleaning complexity of device categories.
• Regulatory and Compliance Officers: Assists in meeting global requirements for reusable medical device processing and traceability.

Practical Benefits:

• Improved Cleaning Outcomes: By grouping devices and matching them to the correct cleaning process, the risk of residual contamination is minimized.
• Efficiency in Validation: Identifying master products streamlines the demonstration of cleaning efficacy for device families.
• Resource Management: Categorization informs the required level of equipment, training, and ongoing competency evaluation, especially for high-complexity device categories.
• Enhanced Communication: Clear manufacturer instructions and established cleaning categories support reliable and safe processing in clinical environments.

Related Standards

Implementation of ISO/TS 17664-3:2026 is closely connected to:

• ISO 17664-1: Outlines the requirements for information to be provided by the medical device manufacturer for processing of medical devices.
• ISO 17664-2: Specifies requirements for processing instructions for health care products not intended to be sterilized.
• ISO 11139: Provides foundational terms and definitions for sterilization and related equipment.
• ISO 15883-5: Establishes cleaning requirements and acceptance criteria for washer-disinfectors.
• AAMI TIR12 / ANSI/AAMI ST98: Offer additional guidance and terminology related to medical device reprocessing.

Conclusion

ISO/TS 17664-3:2026 serves as a key resource for ensuring that reusable medical devices are effectively cleaned, safely reused, and compliant with international best practices. By establishing clear cleaning classification categories, product family groupings, and robust validation protocols, the standard empowers manufacturers and healthcare facilities to safeguard patient safety and optimize device reprocessing.