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 |