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DIN Standards Committee Health Technologies

DIN ISO 11040-6 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 11137-3 2017-11 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More 
DIN EN ISO 14644-1 2016-06 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015); German version EN ISO 14644-1:2015 More 
DIN EN ISO 14937 2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009 More 
DIN EN ISO 15378 2018-04 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017 More 
DIN EN ISO 15747 2019-07 Plastic containers for intravenous injections (ISO 15747:2018); German version EN ISO 15747:2019 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 7886-1 2020-11 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08); German version EN ISO 7886-1:2018 More 
DIN EN ISO 80369-1 2019-08 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018); German version EN ISO 80369-1:2018 More 
DIN EN ISO 8871-1 2004-11 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English 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