BS EN ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor.

BS EN ISO 17664:2004 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, other means of communicating the information can be used, e.g. user manuals, symbols or wall charts supplied separately.

BS EN ISO 17664:2004 excludes textile devices used in patient draping systems or surgical clothing.

NOTE The principles of BS EN ISO 17664:2004 may be applied when considering the information to be supplied with medical devices which only require disinfection prior to re-use.

Cross References:

93/42/EEC
ISO 11134:1994
EN 285:1996
ISO 11135:1994
ISO 11607:1997
EN ISO 14937:2000
ISO 14937:2000
ISO 15223:2000
ISO 7000:1989