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 11608-1:2012); German version EN ISO 11608-1:2012— 49 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.
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995); German version EN ISO 7886-1:1996— 20 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.
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 3: Finished cartridges; Requirements and test methods (ISO 11608-3:2000); German version EN ISO 11608-3:2000— 14 стр.
Needle-based injection systems - Requirements and test methods - Part 3: Finished containers (ISO/DIS 11608-3:2010); German version prEN ISO 11608-3:2010
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 11608-1:2012); German version EN ISO 11608-1:2012— 49 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.