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 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017— 93 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.
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.
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2003); German version EN ISO 3826-1:2003— 31 стр.
Plastics collapsible containers for human blood and blood components - Part 4: Apheresis blood bag systems with integrated features (ISO 3826-4:2015); German version EN ISO 3826-4:2015— 51 стр.
Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015); German version EN ISO 8536-8:2015— 23 стр.
Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment (ISO 8536-11:2004); German version EN ISO 8536-11:2004— 12 стр.
Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment (ISO 8536-9:2004); German version EN ISO 8536-9:2004— 12 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.
Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment (ISO 8536-10:2004); German version EN ISO 8536-10:2004— 14 стр.
Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015); German version EN ISO 8536-9:2015— 21 стр.
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015); German version EN ISO 8536-10:2015— 18 стр.
Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus (ISO 8536-8:2004); German version EN ISO 8536-8:2004— 16 стр.
Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015); German version EN ISO 8536-11:2015— 18 стр.
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014— 90 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009— 32 стр.
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.
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015); German version EN ISO 1135-5:2015— 34 стр.
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017— 76 стр.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017— 93 стр.
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014— 24 стр.
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013); German version EN ISO 3826-1:2013— 34 стр.
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010 + Amd 1:2013); German version EN ISO 8536-4:2013 + A1:2013— 26 стр.
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014— 30 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.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012— 33 стр.