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SRPS EN 15424:2008

Статус: Повучен
Језик: Engleski
Бр. страна: 46
Датум: 09.09.2008.
Датум повлачења: 28.02.2018 .
Службени гласник: 89/08
Број решења: 1313/43-51-02/2018
Издање: 1 ED
Веза са међународним стандардима
Ovaj standard je identičan sa:
EN 15424:2007   CEN/TC 204
Цена: 3807 RSD

За читање онлајн


Наслов на српском језику

Sterilizacija medicinskih sredstava - Para niske temperature i formaldehid - Zahtevi za razvoj, validaciju i rutinsku kontrolu procesa sterilizacije za medicinska sredstva

Наслов на енглеском језику

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

Апстракт на српском језику

Ovim dokumentom utvrđuju se zahtevi za razvoj, validaciju i rutinsku kontrolu procesa sterilizacije pomoću para niske temperature i formaldehida za medicinska sredstva. Ovaj standard namenjen je proizvođačima opreme za sterilizaciju, proizvođačima medicinskih sredstava i organizacijama koje su odgovorne za sterilizaciju medicinskih sredstava.

Апстракт на енглеском језику

1.1 Inclusions 1.1.1 This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. 1.1.2 This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1) 1.1.3 This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only. 1.2 Exclusions 1.2.1 Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. 1.2.2 This standard does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556-1. 1.2.3 This standard does not specify a quality management system for the control of all stages of production of medical devices. NOTE Attention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appro

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formaldehid;niske temperature;medicinska oprema;validacija;medicinski produkti