ISO 17664-2:2021

Overview

ISO 17664-2:2021 is an essential international standard published by ISO that specifies requirements for the information to be provided by medical device manufacturers regarding the processing of non-critical medical devices not intended to be sterilized. Non-critical medical devices, as defined here, are devices intended to come into contact only with intact skin or have no direct patient contact. This document guides manufacturers in providing detailed processing instructions to ensure safe and effective processing before use or reuse, covering cleaning, disinfection, drying, inspection, packaging, storage, and transportation.

Complying with ISO 17664-2:2021 helps manufacturers deliver comprehensive, validated information supporting healthcare facilities in maintaining medical device hygiene, reducing the risk of infection, and ensuring patient and staff safety.

Key Topics

• Scope and Purpose: Clarifies the requirement for manufacturers to provide specific information for non-critical medical devices that are not intended to be sterilized, excluding devices needing sterilization or those categorized as critical or semi-critical.
• Processing Stages: Information should enable processing at every applicable stage, including:
  • Preparation before processing
  • Cleaning (manual or automated)
  • Disinfection (manual or automated)
  • Drying
  • Inspection and maintenance
  • Packaging
  • Storage
  • Transportation
• Information Requirements: Manufacturers must provide clear, validated instructions for each processing step, identify necessary equipment and materials, specify process limitations and restrictions, and include any known incompatibilities.
• Risk Analysis and Validation: Emphasizes the need for thorough risk management (referencing ISO 14971) and validation of each process step to ensure effectiveness and safety, including documentation of the methods used.
• Presentation of Information: Processing instructions must be accessible, precise, and available in print or electronic format upon request.

Applications

ISO 17664-2:2021 is particularly valuable for:

• Medical Device Manufacturers: Assists in developing accurate, validated processing instructions that end users can easily follow, ensuring compliance with regulatory requirements and facilitating product acceptance in global markets.
• Healthcare Facilities: Enables effective reprocessing of reusable non-critical medical devices, such as stethoscopes, blood pressure cuffs, beds, and wheelchairs, contributing to improved infection control practices.
• Regulatory Compliance: Helps organizations meet international regulatory demands for medical device reprocessing, ensuring the information supplied with products is consistent with best practices and risk management principles.
• Quality Systems: Supports the implementation and documentation required by quality management systems for medical devices, reinforcing process controls throughout the product lifecycle.
• Training and Education: Provides a recognized reference for training healthcare staff on correct procedures for cleaning, disinfecting, and handling non-critical medical devices.

Related Standards

For a comprehensive approach to medical device processing, consider the following related standards:

• ISO 14971: Medical devices - Application of risk management to medical devices
• ISO 17664-1: Processing of health care products - Information provided by the medical device manufacturer (for critical and semi-critical devices)
• ISO 15883 Series: Washer-disinfectors - Requirements and validation for automated cleaning and disinfection processes
• ISO 20417: Medical devices - Information to be supplied by the manufacturer
• ISO/IEC Directives: Editorial and procedural rules for drafting ISO standards

Applying ISO 17664-2:2021 ensures that information for processing non-critical medical devices is clear, validated, and contributes to the safety and effectiveness of healthcare delivery. Adhering to this standard supports infection prevention strategies and mitigates risks associated with improper device reprocessing.