AAMI ST81

Description / Abstract: This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor.

This standard specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification.

Requirements are specified for processing that consists of all or some of the following activities:

— preparation at the point of use;

— preparation, cleaning, disinfection;

— drying;

— inspection, maintenance, and testing;

— packaging;

— sterilization;

— storage.

When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing. It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards. In this case, a reference in the instructions is all that is required. For those medical devices where instructions for use are not required to accompany the medical device (for instance, simple clamps, forceps, retractors, etc.), other means of communicating the information can be used, e.g., user manuals, symbols, or wall charts supplied separately.

This standard excludes textile devices used in patient draping systems or surgical clothing. ANSI/AAMI ST65:2000 contains information on processing textiles.

NOTE—The principles of this standard may be applied when considering the information to be supplied with medical devices which only require disinfection prior to reuse.