Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008— 108 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.
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.
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.
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004— 23 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.
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.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits; German version EN 12006-2:1998+A1:2009— 16 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.
Electrotechnic; basic environmental testing procedures; mounting of components, equipment and other articles for dynamic tests including shock (Ea), bump (Eb),vibration (Fc and Fd) and steady-state acceleration (Ga) and guidance; identical with IEC 60068-2-47, edition 1982
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007); German version EN ISO 7197:2009— 14 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/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.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007— 75 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
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 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.
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007); German version EN ISO 21535:2009— 18 стр.
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007); German version EN ISO 21536:2009— 15 стр.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents; German version EN 14299:2004— 36 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.
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008— 113 стр.
Metallic and other inorganic coatings - Electrodeposited gold and gold alloy coatings for electrical, electronic and engineering purposes - Specification and test methods (ISO 27874:2008); German version EN ISO 27874:2008— 32 стр.
Aerospace series - Nuts, self-locking, MJ threads, in heat resisting nickel base alloy NI-PH2601 (Inconel 718), MoS<(Index)2> coated - Classification: 1550 MPa (at ambient temperature) / 425 °C - Technical specification; German and English version EN 4048:2004— 40 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.
Corrosion protection of metals - Electrodeposited coatings of zinc with supplementary treatment on iron and steel; German version EN 12329:2000— 9 стр.
Internal and/or external protective coatings for steel tubes - Specification for hot dip galvanized coatings applied in automatic plants; German version EN 10240:1997— 16 стр.
Electrodeposited nickel coatings on magnetic and non-magnetic substrates - Measurement of coating thickness - Magnetic method (ISO 2361:1982); German version EN ISO 2361:1995— 6 стр.
Metallic and other inorganic coatings - Electrodeposited silver and silver alloy coatings for engineering purposes - Specification and test methods (ISO 4521:2008); German version EN ISO 4521:2008— 27 стр.
Metallic coatings - Autocatalytic (electroless) nickel-phosphorus alloy coatings - Specifications and test methods (ISO 4527:2003); German version EN ISO 4527:2003— 31 стр.
Metallic and other non-organic coatings - Definitions and conventions concerning the measurement of thickness (ISO 2064:1996); German version EN ISO 2064:2000— 5 стр.
Materials and articles in contact with foodstuffs - Cutlery and table holloware - Part 4: Requirements for gold plated cutlery (ISO 8442-4:1997); German version EN ISO 8442-4:1997— 13 стр.
Materials and articles in contact with foodstuffs - Cutlery and table holloware - Part 3: Requirements for silver-plated table and decorative holloware (ISO 8442-3:1997); German version EN ISO 8442-3:1997— 13 стр.
