NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 14160 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 11138-1 | 2017-03 | Sterilization of health care products - Biological indicators - Part 1: General requirements More |
| ISO 11138-7 | 2019-03 | Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results More |
| ISO 11139 | 2018-08 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More |
| ISO 11737-2 | 2019-12 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes 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 |
| ISO 18362 | 2016-02 | Manufacture of cell-based health care products - Control of microbial risks during processing More |
| ISO 22442-1 | 2020-09 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management More |
| ISO 22442-2 | 2020-09 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling More |
