Specification for radio disturbance and immunity measuring apparatus and methods - Part 2-1: Methods of measurement of disturbances and immunity - Conducted disturbance measurements (CISPR 16-2-1:2008 + A1:2010) (english version)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO/DIS 14644-10:2011); German version prEN ISO/DIS 14644-10:2011
Cleanrooms and associated controlled environments - Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1 (ISO/DIS 14644-2:2010); German version prEN ISO 14644-2:2010
Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001); German version EN ISO 14644-4:2001— 55 стр.
Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003); German version EN ISO 14698-1:2003— 38 стр.
Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003 + Cor.1:2004) (consolidated version)
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 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 14937:2009)
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.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003— 10 стр.
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements; German version EN 1174-1:1996— 8 стр.
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance; German version EN 1174-2:1996— 13 стр.
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques; German version EN 1174-3:1996— 9 стр.
