Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2007— 24 стр.
Biological evaluation of medical devices - Part 13: Identification and and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998); German version EN ISO 10993-13:1998— 10 стр.
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2001— 20 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 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); German version EN ISO 10993-16:1997— 8 стр.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2002— 31 стр.
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005— 25 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 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006); German version EN ISO 11137-1:2006— 49 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 11607-1:2006— 33 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006— 18 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2003— 30 стр.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2003— 15 стр.
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998); German version EN ISO 14160:1998— 22 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2003— 25 стр.
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices— 7 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.
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys— 5 стр.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents; German version EN 14299:2004— 36 стр.
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO/DIS 10555-3:2011); German version prEN ISO 10555-3:2011
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.
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO/DIS 10555-4:2011); German version prEN ISO 10555-4:2011
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2013); German version prEN ISO 10993-3:2013
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 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); Corrigendum 1 to English translation of DIN EN ISO 10993-7:2009-02— 3 стр.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2007— 28 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2010— 83 стр.
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010— 26 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995); German version EN ISO 10993-7:1995— 34 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008 + Cor 1:2009) (consolidated version)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2006 Amd1:2012); German version EN ISO 11137-1:2006/prA1:2012
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/DAM 1:2013); German version EN ISO 11607-1:2009/prA1:2013
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/DAM 1:2013); German version EN ISO 11607-2:2006/prA1:2013
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)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999); German version EN ISO 10993-9:1999— 7 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)
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.
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.
Corrosion of metals and alloys - Electrochemical test methods - Guidelines for conducting potentiostatic and potentiodynamic polarization measurements (ISO 17475:2005+Cor. 1:2006); German version EN ISO 17475:2008— 20 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)
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002+Amd.1:2006); German version EN ISO 10993-10:2002+A1:2006— 69 стр.
