NA 176
DIN Standards Committee Health Technologies
DIN ISO 11040-6 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN ISO 2859-1 | 2014-08 | Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999 + Cor. 1:2001 + Amd.1:2011); Text in German and English More |
| 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 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 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More |
| ISO 11137-3 | 2017-06 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control 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 |
| ISO 14644-1 | 2015-12 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration More |
| ISO 14937 | 2009-10 | 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 More |
