NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11139 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 61010-2-040 | 2020-05 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials More |
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 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 11135 AMD 1 | 2018-10 | Revision of Annex E, Single batch release More |
| ISO 11137-1 | 2006-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More |
| ISO 11137-1 AMD 1 | 2013-07 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1 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 11138-1 | 2017-03 | Sterilization of health care products - Biological indicators - Part 1: General requirements More |
| ISO 11138-5 | 2017-03 | Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes More |
