NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11737-2 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EUV 2017/746 | 2017-04-05 | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More |
| ISO 10012 | 2003-04 | Measurement management systems - Requirements for measurement processes and measuring equipment 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 11138-2 | 2017-03 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes 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 11737-1 | 2018-01 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14644-1 | 2015-12 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration More |
