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.
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.
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 12: Sample preparation and reference materials (ISO 10993-12:2002); German version EN ISO 10993-12:2004— 24 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); German version EN ISO 17665-1:2006— 51 стр.
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004); German version EN ISO 22803:2005— 14 стр.
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneoulsy breathing humans (ISO 23747:2007); German version EN ISO 23747:2007— 36 стр.
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008— 113 стр.
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S; German version EN 867-5:2001— 24 стр.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes; German version EN 12006-1:1999— 26 стр.
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk; German version EN 12442-1:2000— 16 стр.
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994); German version EN 30993-6:1994— 10 стр.
Biological evaluation of medical devices; part 4: selection of tests for interactions with blood (ISO 10993-4:1992); German version EN 30993-4:1993— 17 стр.
Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000); German version EN ISO 5366-1:2004— 22 стр.
Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000); German version EN ISO 10993-8:2000— 7 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 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 10: Tests for irritation and sensitization (ISO 10993-10:1995); German version EN ISO 10993-10:1995— 27 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002); German version EN ISO 10993-10:2002— 55 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 12: Sample preparation and reference materials (ISO 10993-12:2002); German version EN ISO 10993-12:2004— 24 стр.
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995) (including Amendment A1:1999); German version EN ISO 10555-1:1996 + A1:1999— 11 стр.
Walking aids manipulated by both arms - Requirements and test methods - Part 3: Walking tables (ISO 11199-3:2005); German version EN ISO 11199-3:2005— 32 стр.
Walking aids manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs; German version EN ISO 11334-4:1999— 18 стр.
Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007); German version EN ISO 11334-1:2007— 22 стр.
Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:1999); German version EN ISO 11199-2:1999— 13 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); German version EN ISO 14534:2002— 16 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:1997); German version EN ISO 14534:1997— 10 стр.
Dental implants - Prefabricated parts connecting suprastructures to dental implants - Contents of technical file (ISO 14727:1998); German version EN ISO 14727:1998— 5 стр.
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005); German version EN ISO 14408:2009— 14 стр.
