ISO 17664 Handling of Health Care Products - Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices

ISO 17664 specifies the requirements for information to be provided by the medical device manufacturer for the handling of a medical device that requires cleaning and subsequent disinfection or sterilization to ensure that the device is safe and effective for its intended use.

This standard contains information to be processed before the use or reuse of the medical device. The provisions of ISO 17664 apply to medical devices intended for invasive or other direct or indirect patient contact.

This standard specifies requirements to assist medical device manufacturers in providing detailed processing instructions, where applicable, consisting of the following activities:

• Initial treatment at the point of use;
• Preparation before cleaning;
• Cleaning;
• disinfection;
• Drying;
• Inspection and maintenance;
• Packaging;
• Sterilization;
• Storage;
• Transportation.

This standard does not cover the processing of:

• Non-critical medical devices not designed for direct patient contact;
• Textile devices used in patient drape systems or surgical garments;
• Medical devices specified by the manufacturer for single use only and supplied ready for use.

EUROLAB assists manufacturers with ISO 17664 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.