Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009— 17 стр.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2010); German version prEN ISO 10993-12:2010
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 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010); German version EN ISO 10993-16:2010— 23 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2011); German version prEN ISO 10993-3:2011
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)— 19 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.
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.
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 FprEN ISO 22794:2009— 18 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 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013— 83 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009); German version EN ISO 11980:2009— 36 стр.
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006 + Amd 1:2012); German version EN ISO 11979-7:2006 + A1:2012— 24 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007— 75 стр.
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011— 13 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.
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009— 27 стр.
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2015— 14 стр.
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009); German version EN ISO 80601-2-56:2012— 63 стр.
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011— 70 стр.
