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EVS-EN ISO 13408-5:2011

Tervishoiutoodete aseptiline töötlemine. Osa 5: Kohapeal steriliseerimine (ISO 13408-5:2006)

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Kehtiv alates 03.08.2011
Alusdokumendid
ISO 13408-5:2006; EN ISO 13408-5:2011
Standardi ajalugu
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Kuupäev
Tüüp
Nimetus
03.08.2011
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EVS-EN 13824:2005
1.1 This part of ISO 13408 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. NOTE SIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steam sterilization in place, which is the most common method used, is given in Annex A. 1.2 This part of ISO 13408 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product. 1.3 This part of ISO 13408 does not apply to processes where equipment is dismantled and delivered to a sterilizer. 1.4 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regional jurisdictions. 1.5 This part of ISO 13408 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
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EVS-EN ISO 13408-4:2011

Tervishoiutoodete aseptiline töötlemine. Osa 4: Kohapeal puhastamise tehnoloogiad (ISO 13408-4:2005)
Uusim versioon Kehtiv alates 03.08.2011
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EVS-EN ISO 13408-1:2015

Tervishoiutoodete aseptiline töötlemine. Osa 1: Üldnõuded
Uusim versioon Kehtiv alates 02.07.2015
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EVS-EN ISO 13408-6:2011

Tervishoiutoodete aseptiline töötlemine. Osa 6: Isolaatorsüsteemid (ISO 13408-6:2005)
Uusim versioon Kehtiv alates 03.08.2011
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EVS-EN ISO 13408-2:2011

Tervishoiutoodete aseptiline töötlemine. Osa 2: Filtreerimine (ISO 13408-2:2003)
Kehtetu alates 02.04.2018