Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006— 2 стр.
Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers; German version EN 866-2:1997— 6 стр.
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements; German version EN 1174-1:1996— 8 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.
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003— 56 стр.
Guidance on the application of EN 29001 and EN 46001 and EN 29002 and EN 46002 for the active (including active implantable) medical device industry; German version EN 50103:1995— 17 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.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001— 8 стр.
Lung ventilators - Part 1: Particular requirements for critical care ventilators (includes Amendment A1:2000); German version EN 794-1:1997 + A1:2000— 36 стр.
Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods; German version EN 868-1:1997— 15 стр.
Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers; German version EN 866-2:1997— 6 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001— 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.
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.
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 - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2005— 38 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.
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.
