NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 16061 [Withdrawn] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 |
| IEC 60068-2-27 | 2008-02 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock More |
| IEC 60068-2-31 | 2008-05 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens More |
| IEC 60068-2-47 | 2005-04 | Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests More |
| ISO 10993-14 | 2001-11 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More |
| ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More |
| ISO 11140-3 | 2007-03 | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test More |
| ISO 11140-4 | 2007-03 | Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration More |
| ISO 11140-5 | 2007-03 | Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests More |
| ISO 14937 | 2009-10 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices More |
