NA 176

DIN Standards Committee Health Technologies

DIN ISO 11040-4 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-7 2008-10 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More 
ISO 11040-5 2012-01 Prefilled syringes - Part 5: Plunger stoppers for injectables More 
ISO 7864 2016-08 Sterile hypodermic needles for single use - Requirements and test methods More 
ISO 8871-1 2003-10 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates More 
ISO 9626 2016-08 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods More 
DIN EN ISO 11140-1 2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014 More 
DIN EN ISO 11140-3 2009-09 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007); German version EN ISO 11140-3:2009 More 
DIN EN ISO 11140-4 2007-07 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007 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