Verkkokauppa
SFS-EN ISO 13408-2:2018:en
Aseptic processing of health care products. Part 2: Sterilizing filtration (ISO 13408-2:2018)
Soveltamisala
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ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing 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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing 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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11139:2018 Sterilization of health care products -- Vocabulary of terms used in sterilization and related equipment and process standards
ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11139:2018 Sterilization of health care products -- Vocabulary of terms used in sterilization and related equipment and process standards
Tekninen komitea
Direktiivi
90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
http://ec.europa.eu »
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
http://ec.europa.eu »
Vahvistuspäivä
29.03.2018
Julkaisupäivä
03.04.2018
Painos
2
Sivumäärä
45
Julkaisun kieli
englanti