SFS-EN ISO 13408-5:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

ISO 13408-5:2006 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.
ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

ISO 11138-1:2006 Sterilization of health care products -- Biological indicators -- Part 1: General requirements
ISO 11138-2:2006 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-3:2006 Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes

ISO 11138-1:2006 Sterilization of health care products -- Biological indicators -- Part 1: General requirements
ISO 11138-2:2006 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-3:2006 Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-4:2006 Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2006 Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11140-1:2005 Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
ISO 11140-3:2007 Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 11140-3:2007/Cor 1:2007
ISO 11140-4:2007 Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 11140-5:2007 Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO 13408-1:2008 Aseptic processing of health care products -- Part 1: General requirements
ISO 13408-4:2005 Aseptic processing of health care products -- Part 4: Clean-in-place technologies
ISO 14161:2009 Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/IEC 90003:2004

Tekninen komitea

CEN/TC 204 Sterilization of medical devices »

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 »

Vahvistuspäivä

15.08.2011

Julkaisupäivä

02.09.2011

Painos

1

Sivumäärä

21

Julkaisun kieli

englanti