Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015— 38 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015— 92 стр.
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009— 28 стр.
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013— 64 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999); German version EN ISO 14644-1:1999— 17 стр.
Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000); German version EN ISO 14644-2:2000— 9 стр.
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 - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004— 60 стр.
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013); German version EN ISO 14644-8:2013— 28 стр.
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012); German version EN ISO 14644-9:2012— 32 стр.
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013); German version EN ISO 14644-10:2013— 40 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); German version EN ISO 14698-2:2003— 15 стр.
Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003); German version EN ISO 14698-2:2003, Corrigendum to DIN EN ISO 14698-2:2004-02; German version EN ISO 14698-2:2003/AC:2006— 2 стр.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012— 112 стр.
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO/DIS 14644-1:2014); German version prEN ISO 14644-1:2014
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO/DIS 14644-2:2014); German version prEN ISO 14644-2:2014
Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003 + Cor.1:2004) (consolidated version)
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version FprEN ISO 13408-7:2015— 38 стр.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015— 43 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015— 19 стр.
