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Norm

ISO 17664:2004

Issue date: 2004 02 25

Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices

ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical ...
Withdrawn: 2017 10 25
Publisher:
International Organization for Standardization
Format:
Digital | 18 Pages
Language:
English

ISO 17664:2004 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. 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:

a) preparation at the point of use;

b) preparation, cleaning, disinfection;

c) drying;

d) inspection, maintenance and testing;

e) packaging;

f) sterilization;

g) 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.

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

ISO 17664:2004 is not applicable to textile devices used in patient-draping systems or surgical clothing.

ISO 17664-1:2021
2021 07 06
Processing of health care products — Information to be provided by the medical device manufacturer f...
Norm
ISO 17664:2017
2017 10 25
Processing of health care products — Information to be provided by the medical device manufacturer f...
Norm
ISO 17664:2004
2004 02 25
Sterilization of medical devices — Information to be provided by the manufacturer for the processing...
Norm
Norm
ISO 17664:2017
Issue date : 2017 10 25
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices