NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11135 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10012 | 2003-04 | Measurement management systems - Requirements for measurement processes and measuring equipment More |
| ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More |
| ISO 11140-1 | 2014-11 | Sterilization of health care products - Chemical indicators - Part 1: General requirements 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 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 |
| DIN EN ISO 10012 | 2004-03 | Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 More |
| DIN EN ISO 10993-11 | 2018-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018 More |
| DIN EN ISO 10993-13 | 2010-11 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010 More |
| DIN EN ISO 10993-14 | 2009-08 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 More |
| DIN EN ISO 10993-16 | 2018-02 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017 More |
