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ICS (a szabványok nemzetközi osztályozási rendszere) szerinti keresés

Nettó ár: 13780 Ft
Kosárba tesz
Alapadatok
Hivatkozási szám
MSZ EN ISO 25424:2012
Dokumentumazonosító
152890
Cím
Orvostechnikai eszközök sterilizálása. Kis hőmérsékletű gőz és formaldehid. Az orvostechnikai eszközök sterilizálási folyamatának fejlesztési, validálási és rutin-ellenőrzési követelményei (ISO 25424:2009)
Angol cím
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
Alkalmazási terület
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 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 appropriate places in the text. 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. Further guidance is given in E.2 of EN ISO 14937:2000. 1.2.4 This standard does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. NOTE 1 Safety requirements for sterilizers are specified in EN 61010-2-040. NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements. 1.2.5 This European Standard does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. NOTE 1 Attention is drawn to EN 14180. NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation specifying limits for the level of formaldehyde residues on medical devices and products. 1.2.6 This European Standard does not cover preparatory measures that may be necessary before sterilization such as cleaning, disinfection and packing. NOTE For re-sterilizable medical devices, the manufacturer(s) of these devices should supply information on the preparatory measures (see EN ISO 17664).
ICS
11.080.01 Sterilezés és fertőtlenítés általában
Műszaki Bizottság
A szabvány nyelve
angol
Az érvényesség kezdete
2012-01-01
A visszavonás napja
2020-05-01
További adatok
Forrás
idt EN ISO 25424:2011; idt ISO 25424:2009
Módosítás
SZK-közlemények
Kapcsolódó európai jogszabály
Kereskedelmi adatok
A szabvány
kapható formátuma
Papír ,
PDF (letöltés) (a fájl mérete: 629922) ,
oldalszáma
49 oldal; T kategória
ára
Nettó: 13780 Ft
Bruttó:
Papír formátum esetén (5% Áfával): 14469 Ft
PDF (letöltés) formátum esetén (27% Áfával): 17501 Ft
Szabvány életútja
Megtekintett szabvány

MSZ EN ISO 25424:2012

2012-01-01 - 2020-05-01