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.
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.
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.
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.
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/FDAM 1:2011); German version EN ISO 14253-1:1998/prA1:2011
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
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.
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 - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011); German version EN ISO 23908:2011— 19 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/DIS 11608-5:2010); German version prEN ISO 11608-5:2010
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.
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015); Text in German and English— 68 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016); German version EN ISO 11608-7:2017— 29 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016); German and English version FprEN ISO 11608-7:2017— 29 стр.
