NF EN ISO 17664
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 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 17664:2004 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.
<p>ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.</p> <p>This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.</p>
- Avant-propos
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1 Domaine d'application
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2 Termes et définitions
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3 Informations devant être fournies par le fabricant du dispositif médical
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4 Présentation des informations
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5 Validation des informations fournies en matière de retraitement
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6 Analyse du risque
- Annexe A (informative) Méthodes de retraitement couramment utilisées
- Annexe B (informative) Exemple d'instructions de retraitement de dispositifs médicaux réutilisables
- Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE
- Bibliographie
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