Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2005— 38 стр.
Data elements and interchange formats; information interchange; representation of dates and times (ISO 8601:1988 and its technical corrigendum 1:1991); german version EN 28601:1992— 14 стр.
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (includes Corrigendum 1:1999 (A1:1999) and Amendment A2:2000); German version EN 552:1994 + Corrigendum 1:1999 (A1:1999) + Amendment A2:2000— 29 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006— 2 стр.
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003— 56 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007— 52 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007, Corrigendum to DIN EN ISO 11137-2:2007-09; German version EN ISO 11137-2:2007/AC:2009— 2 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2009— 34 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007— 75 стр.
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000); German version EN ISO 14161:2000— 46 стр.
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); German version EN ISO 15882:2008— 40 стр.
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); German and English version EN ISO/IEC 17025:2005, Corrigenda to DIN EN ISO/IEC 17025:2005-08; German and English version EN ISO/IEC 17025:2005/AC:2006— 4 стр.
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 17665-1:2006); German version EN ISO 17665-1:2006— 51 стр.
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006); German version EN ISO 18472:2006— 34 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2009— 39 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2005, Corrigenda to DIN EN ISO 11140-1:2006-04— 4 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2005, Corrigenda to DIN EN ISO 11140-1:2006-04— 4 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2009— 39 стр.
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 11140-4:2007); German version EN ISO 11140-4:2007— 43 стр.
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); German version EN ISO 11140-3:2007— 29 стр.
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); German version EN ISO 15882:2008— 40 стр.
Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources— 26 стр.
