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.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.
Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing; German version EN 14931:2006— 36 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.
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.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006), text in German and English— 110 стр.
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007); German version EN ISO 7197:2009— 14 стр.
Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008); German version EN ISO 9170-2:2008— 31 стр.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009— 38 стр.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004); German version EN ISO 10651-6:2004— 41 стр.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2002— 31 стр.
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007); German version EN ISO 8185:2007— 62 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.
Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms (ISO 9703-3:1998); German version EN ISO 9703-3:1998— 8 стр.
Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008); German version EN ISO 9170-2:2008— 32 стр.
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005— 25 стр.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002); German version EN ISO 10993-12:2004— 24 стр.
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007); German version EN ISO 8835-3:2007— 34 стр.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004); German version EN ISO 10651-2:2004— 46 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006); German version EN ISO 11137-2:2006— 76 стр.
Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006); German version EN ISO 16201:2006— 18 стр.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.
