Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008, Corrigendum to DIN EN ISO 9001:2008-12; Trilingual version EN ISO 9001:2008/AC:2009— 20 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2009— 27 стр.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); German version EN ISO 10993-4:2009— 50 стр.
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2009— 31 стр.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)— 19 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009— 68 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009— 75 стр.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (Revision of EN 46002:1996) (Identical to ISO 13488:1996); German version EN ISO 13488:2000— 13 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.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009— 35 стр.
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15); German version EN ISO 22794:2009— 18 стр.
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007); German version EN ISO 22794:2007— 16 стр.
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007); German version FprEN ISO 22794:2009— 18 стр.
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009); German version EN ISO 26782:2009— 36 стр.
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009)— 36 стр.
Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro-methods (ISO 10993-5:1999); German version EN ISO 10993-5:1999— 8 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); German version EN ISO 10993-15:2000— 16 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); German version EN ISO 10993-15:2009— 21 стр.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002+Amd.1:2006); German version EN ISO 10993-4:2002+A1:2006— 48 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)— 54 стр.
Sterilization of health care products - General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000); German version EN ISO 14937:2000— 37 стр.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); German version EN ISO 10993-4:2009— 50 стр.
