Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012); German version EN ISO 11608-1:2012— 49 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.
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment— 190 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.
Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for proving conformity or nonconformity with specification (ISO 14253-1:2013)
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012— 24 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012); German version EN ISO 11608-3:2012— 18 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014); German version EN ISO 11608-1:2015— 52 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013— 83 стр.
Uncertainty of measurement -- Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) -- Supplement 2: Extension to any number of output quantities— 84 стр.
Electromagnetic compatibility (EMC) - Part 4-29: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations on d.c. input power port immunity tests— 37 стр.
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design— 60 стр.
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests— 188 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; basis environmental testing procedures; test Fc and guidance: vibration (sinusoidal); identical with IEC 60068-2-6:1982 (status as of 1985)
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.
Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for proving conformance or non-conformance with specifications (ISO 14253-1:1998); German version EN ISO 14253-1:1998— 17 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.
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006); German version EN ISO 11608-4:2007— 18 стр.
Pen-injectors for medical use - Part 3: Finished cartridges; Requirements and test methods (ISO 11608-3:2000); German version EN ISO 11608-3:2000— 14 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012); German version EN ISO 11608-2:2012— 25 стр.
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.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/DIS 11608-1:2010); German version prEN ISO 11608-1:2010
Pen-injectors for medical use - Part 3: Finished cartridges; Requirements and test methods (ISO 11608-3:2000); German version EN ISO 11608-3:2000— 14 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012— 24 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014); German version EN ISO 11608-1:2015— 52 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012); German version EN ISO 11608-2:2012— 25 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012); German version EN ISO 11608-3:2012— 18 стр.
