NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11608-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60068-2-6 | 2007-12 | Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal) More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| IEC 60529 | 1989-11 | Degrees of protection provided by enclosures (IP code) More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
| ISO 16269-6 | 2014-01 | Statistical interpretation of data - Part 6: Determination of statistical tolerance intervals More |
| ASTM F 1980 | 2021 | Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices More |
| DIN EN ISO 10993-1 | 2021-05 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 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 10993-9 | 2022-03 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021 More |
