NA 176
DIN Standards Committee Health Technologies
DIN CEN ISO/TS 16775 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 |
| FD S98-053 | 2014-07-02 | Test protocole to perform on reusable sterile barrier systems (containers) in order to evaluate the impermeability of the vat/lid closure More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| IEC 62366-1 Corrigendum 1 | 2016-07 | Medical devices - Part 1: Application of usability engineering to medical devices; Corrigendum 1 More |
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
| ISO 10993-13 | 2010-06 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More |
| ISO 10993-7 AMD 1 | 2019-12 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants 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 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More |
