Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008— 113 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 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2003— 25 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.
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 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 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995); German version EN ISO 10993-7:1995— 34 стр.
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.
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.
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.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007— 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.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version FprEN ISO 14155-2:2009, Amendment 1
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.
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); Corrigendum to DIN EN ISO 14937:2001-05; German version EN ISO 14937:2000/AC:2005— 2 стр.
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys— 5 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.
Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids; requirements and test methods; German version EN 868-10:2000— 7 стр.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices; German version EN 12006-3:1998+A1:2009— 16 стр.
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995 + AMD 1:1999 + AMD 2:2004); German version EN ISO 10555-1:1996 + A1:1999 + A2:2004— 22 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2009— 27 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 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008— 108 стр.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999); German version EN ISO 10993-9:2009— 18 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.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2009— 28 стр.
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998); German version EN ISO 10993-13:2009— 24 стр.
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009— 23 стр.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); German version EN ISO 10993-16:2009— 21 стр.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009— 38 стр.
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009— 28 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137-2:2009); German version prEN ISO 11137-2:2009
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, Corrigenda to DIN EN ISO 11607-1:2006-07— 2 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); English version FprEN ISO 14155-1:2009, Amendment 1
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/DIS 14160:2009); German version prEN ISO 14160:2009
Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007, Corrigenda to DIN EN ISO 14971:2007-07— 2 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.
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005); German version EN ISO 25539-1:2009— 112 стр.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents; German version EN 14299:2004— 36 стр.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents; German version EN 14299:2004— 36 стр.
Gas-fired central heating boilers - Type B<(Index)11> and B<(Index)11BS> boilers fitted with atmospheric burners of nominal heat input not exceeding 70 kW; German version EN 297:1994 + A1:1994 + A2:1996 + A3:1996— 74 стр.
Heating boilers - Part 1: Heating boilers with forced draught burners - Terminology, general requirements, testing and marking; German version EN 303-1:1999— 19 стр.
Gas-fired central heating boilers - Type B<(Index)11> and B<(Index)11BS> boilers fitted with atmospheric burners of nominal heat input not exceeding 70 kW; German version EN 297:1994— 63 стр.
Heating boilers - Part 4: Heating boilers with forced draught burners; special requirements for boilers with forced draught oil burners with outputs up to 70 kW and a maximum operating pressure of 3 bar; terminology, special requirements, testing and marking; German version EN 303-4:1999— 20 стр.
Arc-welded joints in aluminium and its weldable alloys - Guidance on quality levels for imperfections (ISO 10042:1992); German version EN 30042:1994— 14 стр.
Metal-arc welding with covered electrode, gas-shielded metal-arc welding and gas welding; joint preparations for steel (ISO 9692:1992); German version EN 29692:1994— 14 стр.
Welding - Fusion-welded joints in steel, nickel, titanium and their alloys (beam welding excluded) - Quality levels for imperfections (ISO 5817:2003); German version EN ISO 5817:2003— 34 стр.
Welding and allied processes - Joint preparation - Part 2: Submerged arc welding of steels (ISO 9692-2:1998, includes Corrigendum AC:1999); German version EN ISO 9692-2:1998 + AC:1999— 13 стр.
Technical drawings - Symbolic presentation and indication of adhesive, fold and pressed joints (ISO 15785:2002); German version EN ISO 15785:2002— 13 стр.
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005); German version EN ISO 25539-1:2009— 112 стр.
