Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (Revision of EN 46002:1996) (Identical to ISO 13488:1996); German version EN ISO 13488:2000— 13 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.
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.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003— 10 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.
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products; German version EN 13795-1:2002+A1:2009— 17 стр.
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products; German version EN 13795-1:2002— 15 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); German version EN ISO 14534:2009— 20 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 health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000); German version EN ISO 14161:2000— 46 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO/DIS 14534:2009); German version prEN ISO 14534:2009— 20 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.
