Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
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.
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.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014, Corrigendum to DIN EN ISO 11607-1:2014-11— 2 стр.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016
Fine-cut tobacco and smoking articles made from it - Methods of sampling, conditioning and analysis - Part 3: Determination of total particulate matter of smoking articles using a routine analytical smoking machine, preparation for the determination of water and nicotine, and calculation of nicotine-free dry particulate matter (ISO 15592-3:2008)— 39 стр.
Fine-cut tobacco and smoking articles made from it - Methods of sampling, conditioning and analysis - Part 3: Determination of total particulate matter of smoking articles using a routine analytical smoking machine, preparation for the determination of water and nicotine, and calculation of nicotine-free dry particulate matter (ISO 15592-3:2003)— 39 стр.
