Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009— 35 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.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012— 112 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM— 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.
Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) (IEC 60068-2-30:2005); German version EN 60068-2-30:2005— 15 стр.
Electrical engineering; basic environmental testing procedures; test Db and guidance: damp heat, cyclic (12 + 12-hour cycle); identical with IEC 60068-2-30, edition 1980 (status as of 1985)
Electrical engineering; classification of environmental conditions; classification of groups of environmental parameters and their severities; portable and non-stationary use; identical with IEC 60721-3-7:1987
Basic environmental testing procedures - Part 2: Tests; test Ec: Drop and topple, primarily for equipment-type specimens (IEC 60068-2-31:1969 + A1:1982); German version EN 60068-2-31:1993— 6 стр.
Sampling procedures for inspection by variables. General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics— 98 стр.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012— 33 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2006 Amd1:2012); German version EN ISO 11137-1:2006/prA1:2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013— 86 стр.
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006); German version EN ISO 11137-3:2006— 25 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012— 86 стр.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)
Environmental testing - Part 2: Test methods; test Fh: Vibration, broad-band random (digital control) and guidance (IEC 60068-2-64:1993 + Corrigendum 1993); German version EN 60068-2-64:1994— 27 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)
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.
Classification of environmental conditions - Part 3: Classification of groups of environmental parameters and their severities - Section 7: Portable and non-stationary use (IEC 60721-3-7:1995); German version EN 60721-3-7:1995— 26 стр.
