Medical electrical equipment - Part 1: General requirements for safety; 3. collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:1994); German version EN 60601-1-3:1994— 31 стр.
Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (ISO 21570:2005); German version EN ISO 21570:2005, Corrigenda to DIN EN ISO 21570:2006-02; German version EN ISO 21570:2005/AC:2007— 2 стр.
Surgical instruments - Metallic materials - Part 1: Stainless steel (ISO 7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000— 7 стр.
Dental rotary instruments - Diamond instruments - Part 1: Dimensions, requirements, marking and packaging (ISO 7711-1:1997 + Amd 1:2009); German version EN ISO 7711-1:1998 + A1:2009— 64 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, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006— 2 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.
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 11607-1:2009— 34 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006— 18 стр.
Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes of Gr-type (ISO 13397-2:2005); German version EN ISO 13397-2:2005— 9 стр.
Periodontal curettes, dental scalers and excavators - Part 4: Dental excavators, discoid-type (ISO 13397-4:1997); German version EN ISO 13397-4:1997— 6 стр.
Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:1995); German version EN ISO 13402:2000— 7 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009— 32 стр.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009— 17 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.
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.
