NA 176
DIN Standards Committee Health Technologies
DIN ISO 11040-6 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 7864 | 2016-08 | Sterile hypodermic needles for single use - Requirements and test methods More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 7886-1 | 2017-05 | Sterile hypodermic syringes for single use - Part 1: Syringes for manual use 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 11135 | 2020-04 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More |
| 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 |
