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SRPS EN ISO 17664:2008

Статус: Повучен
Језик: Engleski
Бр. страна: 24
Датум: 09.09.2008.
Датум повлачења: 25.06.2018 .
Службени гласник: 89/08
Број решења: 5253/38-51-02/2018
Издање: 1 ED
Веза са међународним стандардима
Ovaj standard je identičan sa:
EN ISO 17664:2004   CEN/TC 204
Цена: 2737 RSD

За читање онлајн

Одштампај

Наслов на српском језику

Sterilizacija medicinskih sredstava - Informacija koju obezbeđuje proizvođač prilikom procesa resterilizacije medicinskih sredstava

Наслов на енглеском језику

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

Апстракт на српском језику

Ovim standardom utvrđuju se informacija koju obezbeđuje proizvođač kod procesa resterilizacije medicinskih sredstava tako da se medicinsko sredstvo može obrađivati bezbedno sa njegovim utvrđenim performansama.

Апстракт на енглеском језику

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.

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Национални пропис

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Национална активност



Дескриптори

medicinska oprema;medicinski produkti;pakovanja;sterilizatori;validacija