NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 14160 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EN 556-1 | 2001-10 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices More |
| EUV 2017/745 | 2017-04-05 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 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 11137-1 | 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 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 |
