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DIN Standards Committee Health Technologies

DIN EN ISO 11608-2 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 13485 2021-12 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 More 
DIN EN ISO 7864 2016-12 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016); German version EN ISO 7864:2016 More 
DIN EN ISO 9001 2015-11 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More 
DIN EN ISO 9626 2016-12 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016 More 
DIN ISO 13926-2 2018-07 Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use (ISO 13926-2:2017) More 
DIN ISO 7000 2008-12 Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750) More 
ISO 11135 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-1 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 13926-2 2017-11 Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use More