Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013); German version EN ISO 5840-3:2013— 122 стр.
Plastics - Determination of apparent density of moulding material that cannot be poured from a specified funnel (ISO 61:1976); German version EN ISO 61:1999— 3 стр.
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, corrected version 2014-01-15 + Amd 1:2017) (consolidated version)
Plastics - Determination of tensile properties - Part 2: Test conditions for moulding and extrusion plastics (ISO 527-2:2012); German version EN ISO 527-2:2012— 18 стр.
Plastics - Determination of tensile properties - Part 3: Test conditions for films and sheets (ISO 527-3:1995 + Corr 1:1998 + Corr 2:2001) (includes Corrigendum AC:1998 + AC:2002); German version EN ISO 527-3:1995 + AC:1998 + AC:2002— 7 стр.
Determination of tensile properties of plastics - Part 4: Test conditions for isotropic and orthotropic fibre-reinforced plastic composites (ISO 527-4:1997)— 11 стр.
Plastics - Determination of tensile properties - Part 5: Test conditions for unidirectional fibre-reinforced plastic composites (ISO 527-5:2009)— 19 стр.
Paints and varnishes - Determination of scratch resistance - Part 1: Constant-loading method (ISO 1518-1:2011); German version EN ISO 1518-1:2011— 14 стр.
Paints and varnishes - Determination of scratch resistance - Part 2: Variable-loading method (ISO 1518-2:2011); German version EN ISO 1518-2:2011— 14 стр.
Quality requirements for fusion welding of metallic materials - Part 1: Criteria for the selection of the appropriate level of quality requirements (ISO 3834-1:2005); German version EN ISO 3834-1:2005— 12 стр.
Quality requirements for fusion welding of metallic materials - Part 2: Comprehensive quality requirements (ISO 3834-2:2005); German version EN ISO 3834-2:2005— 15 стр.
Quality requirements for fusion welding for metallic materials - Part 3: Standard quality requirements (ISO 3834-3:2005); German version EN ISO 3834-3:2005— 14 стр.
Quality requirements for fusion welding of metallic materials - Part 4: Elementary quality requirements (ISO 3834-4:2005); German version EN ISO 3834-4:2005— 8 стр.
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996); German version EN ISO 5832-3:2012— 12 стр.
Plastics - Determination of dynamic mechanical properties - Part 2: Torsion-pendulum method (ISO 6721-2:2008); German version EN ISO 6721-2:2008— 19 стр.
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004); German version EN ISO 10555-1:2009— 22 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.
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.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012); German version EN ISO 11137-2:2012— 86 стр.
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006); German version EN ISO 11137-3:2006— 25 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 11607-1:2009— 34 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 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012— 86 стр.
Textiles - Tensile properties of fabrics - Part 1: Determination of maximum force and elongation at maximum force using the strip method (ISO 13934-1:1999); German version EN ISO 13934-1:1999— 13 стр.
Textiles - Tear properties of fabrics - Part 2: Determination of tear force of trouser-shaped test specimens (single tear method) (ISO 13937-2:2000); German version EN ISO 13937-2:2000— 11 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.
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); German version EN ISO 14160:2011— 48 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)— 54 стр.
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— 73 стр.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); German version EN ISO 22442-1:2007— 36 стр.
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); German version EN ISO 22442-2:2007— 23 стр.
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007— 31 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.
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008); German version CEN ISO/TS 11135-2:2008, Corrigendum to DIN ISO/TS 11135-2:2008-11; German version CEN ISO/TS 11135-2:2008/AC:2009
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020— 60 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020— 23 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
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 14160:2018); German and English version prEN ISO 14160:2018
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017— 65 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)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020— 47 стр.
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020— 30 стр.
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020— 60 стр.
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020); German and English version prEN ISO 10993-2:2020
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 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019— 68 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - AMENDMENT 1 (ISO 11137-2:2013/DAM 1:2021); German and English version EN ISO 11137-2:2015/prA1:2021
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021); German version EN ISO 5840-3:2021— 75 стр.
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques (ISO/DIS 5840-3:2011); German version prEN ISO 5840-3:2011
Fibre-reinforced plastic composites - Declaration of raw material characteristics - Part 2: Specific requirements for resin, curing systems, additives and modifiers; German version EN 16245-2:2013— 22 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 - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021); German version EN ISO 5840-3:2021— 75 стр.
