EN ISO 17664-1 Handling of Health Care Products - Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices - Critical and Semi-Critical Medical Devices

This standard specifies the requirements for information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body, or a medical device in contact with the mucosa).

This standard contains information to be processed before the use or reuse of the medical device.

Machining instructions are not defined in this document. Instead, this document specifies requirements to assist medical device manufacturers in providing detailed processing instructions, which, when applicable, consists 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 document does not cover the processing of:

• Non-critical medical devices unless they are intended to be sterilized;
• 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.

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