Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995); German version EN ISO 10993-7:1995— 34 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.
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.
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); German version EN ISO 14937:2000— 37 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.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes; German version EN 12006-1:1999— 26 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— 8 стр.
Non-active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices; German version EN 12006-3:1998— 8 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.
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); German version EN ISO 7197:2006, Corrigendum to DIN EN ISO 7197:2006-09; German version EN ISO 7197:2006/AC:2008— 2 стр.
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.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008— 108 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007— 76 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, 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.
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.
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 21535:2007— 16 стр.
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007); German version EN ISO 21536:2007— 12 стр.
